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The State Food and Drug Administration announced on the approval and registration of 339 medical device products

 Last Update: 2023-02-02
 Source: Internet
 Author: User

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In December 2022, the State Food and Drug Administration approved the registration of a total of 339 medical device products
.
Among them, there are 273 domestic Class III medical device products, 37 imported Class III medical device products, 25 imported Class II medical device products, and 4 Hong Kong, Macao and Taiwan medical device products (see Annex for specific products).

In 2022,
a total of 2,500 medical device products will be approved for registration.

This is hereby announced
.

Attachment: The catalogue of registered medical devices was approved in December 2022

serial number	Product name	Name of the registrant	Certificate number
Domestic Class III medical devices
1	Single-use pressure monitoring magnetically positioned radiofrequency ablation catheters	Shanghai MicroPort Electrophysiology Medical Technology Co. , Ltd	National Arms Note 20223011571
2	Liver function shear wave quantification detector	Wuxi Hayskell Medical Technology Co. , Ltd	National Arms Note 20223071572
3	Single-use plasma surgical electrodes	Beijing Jesse Huizhong Technology Co. , Ltd	National Arms Annotation 20223011573
4	Semiconductor laser treatment instrument	Wuhan Boqi Century Technology Co. , Ltd	National Arms Note 20223091574
5	Cardiac electrophysiology 3D mapping system	Sichuan Jinjiang Electronic Medical Device Technology Co. , Ltd	National Arms Approval 20223071575
6	Ketamine urine test kit (colloidal gold immunochromatography)	Shenzhen Yirui Biotechnology Co. , Ltd	National Arms Approval 20223401576
7	Multi-parameter monitor	Shanghai Sanefu Electronics Co. , Ltd	National weapons are approved 20223071577
8	Stereotactic cone collimator	Suzhou Leitai Medical Technology Co. , Ltd	National Arms Approval 20223051578
9	X-ray computed tomography equipment	Sino Veston Medical Technology (Yangzhou) Co. , Ltd	National Arms Approval 20223061579
10	Medical magnetic resonance imaging system	Philips Medical (Suzhou) Co. , Ltd	National Arms Note 20223061580
11	Patient monitors	Shenzhen Keman Medical Equipment Co. , Ltd	National Arms Note 20223071581
12	Portable electric injection pump	Jiangsu Aipeng Medical Technology Co. , Ltd	National Arms Note 20223141582
13	X-ray computed tomography equipment	Shanghai United Imaging Medical Technology Co. , Ltd	National Arms Note 20223061583
14	Ventilators	Shenzhen Pubo Medical Technology Co. , Ltd	National Arms Note 20223081584
15	Single-use endovascular ultrasound to diagnose catheters	Tianjin Hengyu Medical Technology Co. , Ltd	National Arms Note 20223061585
16	Novel coronavirus (2019-nCoV) IgG antibody detection kit (magnetic particle chemiluminescence method)	Xiamen Wantai Carey Biotechnology Co. , Ltd	National Arms Approval 20223401586
17	Novel coronavirus (2019-nCoV) IgM antibody detection kit (magnetic particle chemiluminescence method)	Xiamen Wantai Carey Biotechnology Co. , Ltd	National Arms Note 20223401587
18	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Jiangsu Meike Medical Technology Co. , Ltd	National Arms Note 20223401588
19	X-ray computed tomography equipment	Philips Medical (Suzhou) Co. , Ltd	National Arms Note 20223061589
20	X-ray computed tomography equipment	Kangda Intercontinental Medical Equipment Co. , Ltd	National Arms Note 20223061590
21	Positron emission and X-ray computed tomography system	Sichuan Mingfeng Medical Technology Co. , Ltd	National Arms Note 20223061591
22	Ultrasound soft tissue cutting hemostatic device	Suzhou Ruino Medical Technology Co. , Ltd	National weapons are approved 20223011592
23	Patient monitors	Weihai Weigao Medical Imaging Technology Co. , Ltd	National Arms Note 20223071593
24	Positron emission and X-ray computed tomography system	Beijing GE Hualun Medical Equipment Co. , Ltd	National Arms Note 20223061594
25	Endoscopic surgery power equipment	Jiangsu Bangshi Medical Technology Co. , Ltd	National Arms Note 20223011595
26	Hepatitis E virus IgG antibody (HEV-IgG) test kit (photoexcited chemiluminescence)	Kemei Diagnostic Technology Co. , Ltd	National Arms Note 20223401596
27	Ultrasound soft tissue cutting hemostatic device	Taihui (Shandong) Medical Technology Co. , Ltd	National Arms Note 20223011597
28	Epstein-Barr virus nucleic acid detection kit (real-time PCR method)	Jiangsu Mole Biotechnology Co. , Ltd	National Arms Note 20223401598
29	Multiple drug saliva combined detection kit (colloidal gold method)	Hangzhou LONGi Biotechnology Co. , Ltd	National Arms Note 20223401599
30	Total Prostate-Specific Antigen (tPSA) Test Kit (Fluorescence Immunochromatography)	Key Egg Biotechnology Co. , Ltd	National Arms Note 20223401600
31	Irregular antibody screening controls (microcolumn gel method)	Hefei Tianyi Biotechnology Research Institute Co. , Ltd	National Arms Note 20223401601
32	Novel coronavirus 2019-nCoV nucleic acid detection kit (fluorescent PCR method)	Kayudi Biotechnology Yixing Co. , Ltd	National Arms Note 20223401602
33	Novel coronavirus (2019-nCoV) nucleic acid detection kit (fluorescent PCR method)	Guangzhou Wanfu Biotechnology Co. , Ltd	National Arms Note 20223401603
34	External defibrillation monitors	Shenzhen Keman Medical Equipment Co. , Ltd	National Arms Note 20223081604
35	Single-photon emission computed tomography device	Beijing Xiantong International Pharmaceutical Technology Co. , Ltd	National Arms Note 20223061605
36	Positron emission/X-ray computed tomography scanning system	Shanghai United Imaging Medical Technology Co. , Ltd	National Arms Note 20223061606
37	Novel coronavirus (2019-nCoV) nucleic acid detection kit (isothermal amplification method)	Shanghai Berger Medical Technology Co. , Ltd	National Arms Note 20223401607
38	X-ray computed tomography equipment	Jiangsu Mocott Medical Technology Co. , Ltd	National Arms Note 20223061608
39	Ventilators	Shenzhen Keman Medical Equipment Co. , Ltd	National Arms Note 20223081609
40	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Bioda Biotechnology (Wuhan) Co. , Ltd	National Arms Note 20223401610
41	Single-use plasma surgical electrodes	Zhejiang Quantum Medical Equipment Co. , Ltd	National Arms Note 20223011611
42	Thulium-doped fiber laser treatment machine	Shanghai Ruikeen Laser Technology Co. , Ltd	National Arms Note 20223011612
43	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Key Egg Biotechnology Co. , Ltd	National Arms Note 20223401613
44	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Temp Bioscience (China) Co. , Ltd	National Arms Note 20223401614
45	Single-use magnetically positioned saline injection frequency ablation catheter	Sichuan Jinjiang Electronic Technology Co. , Ltd	National Arms Note 20223011615
46	Single-use microwave ablation needles	Shanghai Weijing Medical Technology Co. , Ltd	National Arms Note 20223011616
47	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Zhongshan Bioengineering Co. , Ltd	National Arms Note 20223401617
48	Mycobacterium tuberculosis complex nucleic acid detection kit (PCR-fluorescent probe method)	Guangzhou Daan Gene Co. , Ltd	National Arms Note 20223401618
49	CD117 antibody reagent (immunohistochemistry)	Wuxi Aorui Dongyuan Biotechnology Co. , Ltd	National Arms Note 20223401619
50	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Zhengzhou Antu Bioengineering Co. , Ltd	National Arms Note 20223401620
51	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Xiamen is Positive Biotechnology Co. , Ltd	National Arms Note 20223401621
52	Alpha-fetoprotein (AFP) assay kit (magnetic particle chemiluminescence)	Shandong Zhonghong Special Inspection Biotechnology Co. , Ltd	National Arms Note 20223401622
53	Abdominal endoscopic surgical system	Shenzhen Jingfeng Medical Technology Co. , Ltd	National Arms Note 20223011623
54	Intracranial balloon dilation catheter	Guangdong Bomai Yuantong Medical Technology Co. , Ltd	National Arms Note 20223031624
55	Neurovascular guidewires	Beijing Shenruida Medical Technology Co. , Ltd	National Arms Note 20223031625
56	Metal strip wire anchors	Tianjin Zhengtian Medical Equipment Co. , Ltd	National Arms Note 20223131626
57	Thoracolumbar posterior nail stick fixation system	Hunan Huaxiang Incremental Manufacturing Co. , Ltd	National Arms Note 20223131627
58	Single-use hemoperfusion devices	Beijing Zhongke Shengkang Technology Co. , Ltd	National Arms Note 20223101628
59	Single-use infusion extension tubes	Shanghai Esai Medical Technology Co. , Ltd	National Arms Note 20223141629
60	Intracranial balloon dilation catheter	Weitai Medical Equipment (Shenzhen) Co. , Ltd	National Arms Note 20223031630
61	Peripheral balloon dilation catheter	Shanghai Bomaian Medical Technology Co. , Ltd	National Arms Note 20223031631
62	Hemodialysis filters	Shandong Xinhua Medical Equipment Co. , Ltd	National Arms Note 20223101632
63	Intervertebral fusion device	Dabo Medical Technology Co. , Ltd	National Arms Note 20223131633
64	One-time use of a human arterial blood sample	Jiangsu Chongheng Medical Technology Co. , Ltd	National Arms Note 20223221634
65	Distal access catheter	Chengdu Barui Hengtong Medical Technology Co. , Ltd	National Arms Note 20223031635
66	Intracranial balloon dilation catheter	Liaoning Yiyi Biotechnology Co. , Ltd	National Arms Note 20223031636
67	Soft hydrophilic contact lenses	Fujian Youyou Kang Optical Co. , Ltd	National Arms Note 20223161637
68	Microcatheters	Shandong Jiwei Medical Products Co. , Ltd	National Arms Note 20223031638
69	Aortic valve balloon dilation catheter	Shanghai New Pulse Medical Technology Co. , Ltd	National Arms Note 20223031639
70	Vertebral body fusion	Zhejiang Jiayou Medical Equipment Co. , Ltd	National Arms Note 20223131640
71	Hydrocolloid oil yarn	Taizhou Rongxing Medical Supplies Co. , Ltd	National Arms Note 20223141641
72	Dental laser selectivity melts cobalt-chromium alloy powder	AVIC Matte Powder Metallurgy Technology (Beijing) Co. , Ltd	National Arms Note 20223171642
73	Sodium carboxymethylcellulose fiber dressing	Qingdao Mingyue Biomedical Materials Co. , Ltd	National Arms Note 20223141643
74	One-time use of arterial indwelling needles	Shenzhen Huixinnuo Technology Co. , Ltd	National Arms Note 20223141644
75	Single-use light-protected infusion with needle	Shandong Weigao Group Medical Polymer Products Co. , Ltd	National Arms Note 20223141645
76	Pulmonary artery balloon dilation catheter	Beijing Guanqiao Medical Technology Co. , Ltd	National Arms Note 20223031646
77	Cross-linked sodium hyaluronate gel for injection	Bloomage Biotechnology Co. , Ltd	National Arms Note 20223131647
78	Neural microguidewires	Shandong Pine Medical Equipment Co. , Ltd	National Arms Note 20223031648
79	Intravascular foreign body grabbers	Hunan Ept Medical Equipment Co. , Ltd	National Arms Note 20223031649
80	Coronary artery guide wire	Shenzhen Macpuge Medical Technology Co. , Ltd	National Arms Note 20223031650
81	Coronary balloon dilation ducts	Sino Medical Science and Technology Co. , Ltd	National Arms Note 20223031651
82	Guide wire	Shenzhen Shunmei Medical Co. , Ltd	National Arms Note 20223031652
83	Single-use injection pumps dispense flexitanks	Shanghai MicroPort Life Science Co. , Ltd	National Arms Note 20223141653
84	Hemodialyzers	Chengdu Ousai Medical Equipment Co. , Ltd	National Arms Note 20223101654
85	Peripheral vascular scoring balloon dilation ducts	Guangdong Bomai Medical Technology Co. , Ltd	National Arms Note 20223031655
86	Va cava filter	Guichuang Tongqiao Medical Technology Co. , Ltd	National Arms Note 20223131656
87	Contrast catheters	Nanjing Kangyou Medical Technology Co. , Ltd	National Arms Note 20223031657
88	Endovascular ultrasound diagnostic equipment	Shenzhen opened Biomedical Technology Co. , Ltd	National Arms Note 20223061658
89	Single-use endovascular ultrasound to diagnose catheters	Shanghai Aisheng Biomedical Technology Co. , Ltd	National Arms Note 20223061659
90	Oral photosensitive zirconia ceramics	Kunshan Bolimai 3D Printing Technology Co. , Ltd	National Arms Note 20223171660
91	Hip prosthesis - femoral stalk	Kuanyue Medical Technology (Beijing) Co. , Ltd	National Arms Note 20223131661
92	Vertebral body fusion	Tianjin Zhengtian Medical Equipment Co. , Ltd	National Arms Note 20223131662
93	Knee tibial pad	Shanghai Boma Medical Technology Co. , Ltd	National Arms Note 20223131663
94	Bone anchor nails are matched with sutures	Yunyi (Beijing) Medical Equipment Co. , Ltd	National Arms Note 20223131664
95	With wire anchors	Hebei Ruihe Medical Equipment Co. , Ltd	National Arms Note 20223131665
96	Implantable drug delivery devices and accessories	Suzhou Hengrui Hongyuan Medical Technology Co. , Ltd	National Arms Note 20223141666
97	Posterior spinal fixation system	Beijing Bangsai Technology Co. , Ltd	National Arms Note 20223131667
98	With loop titanium plate	Hebei Ruihe Medical Equipment Co. , Ltd	National Arms Note 20223131668
99	Single-use intravenous indwelling needles	Shaanxi Zhiyu Huanchen Medical Equipment Co. , Ltd	National Arms Note 20223141669
100	Single-use anti-needle venous infusion needles	Chongqing Pharmaceutical Group Weixun Medical Technology Co. , Ltd	National Arms Note 20223141670
101	Citric acid disinfectant	Hainan Langteng Medical Equipment Co. , Ltd	National Arms Note 20223101671
102	Single-use closure clip	Shandong Weirui Surgical Products Co. , Ltd	National Arms Note 20223021672
103	Intracranial balloon dilation catheter	Liaoning Yiyi Biotechnology Co. , Ltd	National Arms Note 20223031673
104	Intracranial balloon dilation catheter	Shanghai Likai Technology Co. , Ltd	National Arms Note 20223031674
105	Polyetheretherketone interface screws	Beijing Wanjie Tianyuan Medical Equipment Co. , Ltd	National Arms Note 20223131675
106	Rotatable repeatable opening and closing clamp device	Shanghai Wilson Optoelectronic Instrument Co. , Ltd	National Arms Note 20223021676
107	Guide tube	Nanjing Meichuang Medical Technology Co. , Ltd	National Arms Note 20223031677
108	Peripheral vascular microcatheters	Shenzhen Shunmei Medical Co. , Ltd	National Arms Note 20223031678
109	Femoral neck dynamic cross nail system	Chongqing Fuworth Medical Equipment Co. , Ltd	National Arms Note 20223131679
110	Single-use vascular sheath group	Henan Camelman Best Medical Equipment Co. , Ltd	National Arms Note 20223031680
111	Metal bone needles	Chongqing Xike Medical Technology Co. , Ltd	National Arms Note 20223131681
112	Peripheral balloon dilation catheter	Weitai Medical Equipment (Shenzhen) Co. , Ltd	National Arms Note 20223031682
113	Dental implant attachments	Weihai Dopple Medical Equipment Co. , Ltd	National Arms Note 20223171683
114	Polyetheretherketone with wire anchors	Beijing Wanjie Tianyuan Medical Equipment Co. , Ltd	National Arms Note 20223131684
115	Microguidewire	Suzhou Hengrui Jia Lisheng Biomedical Technology Co. , Ltd	National Arms Note 20223031685
116	Intracranial balloon dilation catheter	Yeju Medical Equipment (Shenzhen) Co. , Ltd	National Arms Note 20223031686
117	Guide wire	Foshan Qiyou Medical Technology Co. , Ltd	National Arms Note 20223031687
118	Hemishoulder joint prosthesis	Beijing iKang Yicheng Medical Equipment Co. , Ltd	National Arms Note 20223131688
119	Single-use nerve occlusion needles	Shanghai Esai Medical Technology Co. , Ltd	National Arms Note 20223081689
120	Allogeneic oral filling prosthetic material	Nanjing Wuyuedao Medical Technology Development Co. , Ltd	National Arms Note 20223171690
121	Fertilization culture medium	Dongyun Medical Technology (Shanghai) Co. , Ltd	National Arms Note 20223181691
122	Left atrial guidewire	Shanghai Pushi Medical Equipment Co. , Ltd	National Arms Note 20223031693
123	Adjustable titanium plate with loops	Jiangsu Aihopu Medical Equipment Co. , Ltd	National Arms Note 20223131694
124	With loop titanium plate	Ningbo Zhaoying Medical Equipment Co. , Ltd	National Arms Note 20223131695
125	Soft hydrophilic contact lenses	Jiangsu Shizhun Medical Equipment Co. , Ltd	National Arms Note 20223161696
126	Intracranial balloon dilation catheter	Liaoning Yiyi Biotechnology Co. , Ltd	National Arms Note 20223031697
127	Individually matched abutments and screws	Shanghai Yagu denture Co. , Ltd	National Arms Note 20223171698
128	Peripheral balloon dilation catheter	Ningbo Waike Medical Technology Co. , Ltd	National Arms Note 20223031699
129	Lamina fixation plate system	Shanghai Ruizhi Medical Equipment Co. , Ltd	National Arms Note 20223131700
130	Skull elder plate system	Hunan Huaxiang Medical Technology Co. , Ltd	National Arms Note 20223131701
131	The injection pump is dispensed with a flexitank	AP Scientific Instruments (Jiangsu) Co. , Ltd	National Arms Note 20223141702
132	PTA balloon dilation catheter	Liaoning Yiyi Biotechnology Co. , Ltd	National Arms Note 20223031703
133	Disposable sterile syringe with needle	Henan Xingheng Medical Supplies Co. , Ltd	National Arms Note 20223141704
134	Disposable infusion set with needle	Shandong Weigao Group Medical Polymer Products Co. , Ltd	National Arms Note 20223141705
135	Disposable sterile needle-proof syringe with needle	Jiangxi Kelun Medical Equipment Manufacturing Co. , Ltd	National Arms Note 20223141706
136	Hip prosthesis Ceramic ball head	Zhejiang Kehui Medical Equipment Co. , Ltd	National Arms Note 20223131707
137	Disposable rehydration tubes	Qingdao Purison Pharmaceutical Technology Co. , Ltd	National Arms Note 20223101708
138	Ankle locking bone plate system	Ningbo Zhaoying Medical Equipment Co. , Ltd	National Arms Note 20223131709
139	With locking intramedullary nail system	Wuxi Beida Medical Technology Co. , Ltd	National Arms Note 20223131710
140	Pre-filled catheter irrigator	Shanghai Blood Transfusion Technology Co. , Ltd	National Arms Note 20223141711
141	Polyetheretherketone interface screws	Yunyi (Beijing) Medical Equipment Co. , Ltd	National Arms Note 20223131712
142	Anterior cervical nail plate system	Beijing Ansong Technology Co. , Ltd	National Arms Note 20223131713
143	Single-use microcatheters	Hangzhou Ruivit Medical Technology Co. , Ltd	National Arms Note 20223031714
144	Single-use hemodialyzers	Sichuan Weilisheng Medical Technology Co. , Ltd	National Arms Note 20223101716
145	Dilate the catheter with a balloon under the knee	Nanjing Youdebang Medical Technology Co. , Ltd	National Arms Note 20223031717
146	With loop titanium plate	Tianjin Weiman Biomaterials Co. , Ltd	National Arms Note 20223131718
147	Artificial vertebral bodies	Shandong Weigao Orthopedic Materials Co. , Ltd	National Arms Note 20223131719
148	High nitrogen stainless steel femoral stalk	Tianjin Zhengtian Medical Equipment Co. , Ltd	National Arms Note 20223131720
149	It can cut the abutment, titanium column and screw	Chongqing Xikema Medical Equipment Co. , Ltd	National Arms Note 20223171721
150	Single-use centrifuge cup blood cell recovery device	Beijing Jingjing Medical Equipment Co. , Ltd	National Arms Note 20223101722
151	Single-use light-protected infusion with needle	Heilongjiang Shenghua Medical Equipment Co. , Ltd	National Arms Note 20223141723
152	Single-use scale flow-regulated infusion sets	Henan Camel Sanrui Medical Equipment Co. , Ltd	National Arms Note 20223141724
153	Rib elder plates	Shuojue (Jiangsu) Medical Technology Co. , Ltd	National Arms Note 20223131725
154	Hemodialyzers	Suzhou Zhuoyi Medical Equipment Co. , Ltd	National Arms Note 20223101726
155	Disposable linear laparoscopic cutting stapler and components	Changzhou Kandi Medical Stapler Co. , Ltd	National Arms Note 20223021727
156	Single-use anti-needle sterile injection needles	Shandong Zhushi Pharmaceutical Group Co. , Ltd	National Arms Note 20223141728
157	Single-use ring-handled syringes	Shandong Zhushi Pharmaceutical Group Co. , Ltd	National Arms Note 20223031729
158	Dialysis machine disinfectant	Sichuan Weilisheng Medical Technology Co. , Ltd	National Arms Note 20223101730
159	Intracranial balloon dilation catheter	Hemu (China) Bioengineering Co. , Ltd	National Arms Note 20223031731
160	Neurovascular microguidewires	Suzhou Hengrui Dison Medical Technology Co. , Ltd	National Arms Note 20223031732
161	Metal with locking pulp nails	Tianjin Xinzhong Medical Equipment Co. , Ltd	National Arms Note 20223131733
162	PEEK nail sheath fixing system	Tianjin Liyuan Medical Technology Co. , Ltd	National Arms Note 20223131734
163	Acetabular lining	Beijing Huakang Tianyi Biotechnology Co. , Ltd	National Arms Note 20223131735
164	Disposable sterile syringe with needle	Shanxi Xinhuamei Medical Equipment Co. , Ltd	National Arms Note 20223141736
165	Lamina fixation plate system	Ningbo Zhaoying Medical Equipment Co. , Ltd	National Arms Note 20223131737
166	Single-use precision filtration infusion with needles	Suzhou Linhua Medical Equipment Co. , Ltd	National Arms Note 20223141738
167	Single-use breast atherectomy biopsy needle	Shanghai Xiuneng Medical Equipment Co. , Ltd	National Arms Note 20223011739
168	Negative pressure mixer	Chongqing Fuworth Medical Equipment Co. , Ltd	National Arms Note 20223101740
169	Single-use 3-way stopcock	Henan Jianqi Medical Equipment Co. , Ltd	National Arms Note 20223141741
170	Hemodialyzers	BenQ Biotechnology (Shanghai) Co. , Ltd	National Arms Note 20223101742
171	Metal with locking pulp nails	Zhuomaikang (Xiamen) Medical Equipment Co. , Ltd	National Arms Note 20223131743
172	Metal cable internal fixing system	Opai Mason (Jiangsu) Medical Technology Co. , Ltd	National Arms Note 20223131744
173	X-ray blood irradiator	Qingdao Jinchengyuan Medical Technology Co. , Ltd	National Arms Note 20223101745
	X-ray computed tomography equipment	Kuanteng (Beijing) Medical Equipment Co. , Ltd	National Arms Note 20223061746
	X-ray computed tomography equipment	Henan Mingfeng Medical Technology Co. , Ltd	National Arms Note 20223061747
	Positron emission and X-ray computed tomography system	Hubei Ruishi Digital Medical Imaging Technology Co. , Ltd	National Arms Note 20223061748
	Patient monitors	Shenzhen Keman Medical Equipment Co. , Ltd	National Arms Note 20223071749
	Single-use high-frequency bipolar surgical electrodes	Shandong Kangsheng Medical Equipment Co. , Ltd	National Arms Note 20223011750
	Real-time PCR analyzer	Guangzhou Origin Health Technology Co. , Ltd	National Arms Note 20223221751
	Single-use high-frequency hemostats	Shanghai Elton Medical Equipment Co. , Ltd	National Arms Note 20223011752
	Ultrasonic bone tissue surgery equipment	Guilin Woodpecker Medical Equipment Co. , Ltd	National Arms Note 20223011753
	Single-use high-frequency incision	Suzhou Frankman Medical Equipment Co. , Ltd	National Arms Note 20223011754
	Helicobacter pylori nucleic acid detection kit (PCR fluorescent probe method)	Jiangsu Kangwei Century Biotechnology Co. , Ltd	National Arms Note 20223401755
	Gene sequencer	Beijing Youxun Medical Equipment Co. , Ltd	National Arms Note 20223221756
	Navigation system for hip replacement surgery	Beijing Yidian Lingdong Technology Co. , Ltd	National Arms Note 20223011757
	Real-time PCR analyzer	Guangzhou Daan Gene Co. , Ltd	National Arms Note 20223221758
	Cross-matching controls (microcolumn gel method)	Hefei Tianyi Biotechnology Research Institute Co. , Ltd	National Arms Note 20223401759
	Abnormal prothrombin detection kit (magnetic particle chemiluminescence)	Zhengzhou Antu Bioengineering Co. , Ltd	National Arms Note 20223401760
	Digital fluoroscopic X-ray machine	Shanghai Siemens Medical Equipment Co. , Ltd	National Arms Note 20223061761
	X-ray computed tomography equipment	Shanghai Siemens Medical Equipment Co. , Ltd	National Arms Note 20223061762
	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Avico Biotechnology Co. , Ltd	National Arms Note 20223401763
	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Mike Biotech, Inc	National Arms Note 20223401764
	Intracranial support catheter	Beijing Honghai MicroPort Technology Co. , Ltd	National Arms Note 20223031765
	Neurovascular microguidewires	Suzhou Hengrui Hongyuan Medical Technology Co. , Ltd	National Arms Note 20223031766
	One-time use of non-compliant coronary balloon dilation catheters	Dongguan Tiantian Upward Medical Technology Co. , Ltd	National Arms Note 20223031767
	Dural (spine) membrane patch	Zhuo Ruan Medical Technology (Suzhou) Co. , Ltd	National Arms Note 20223131768
	Transperilateral puncture of the midline catheter	Suzhou Bidi Medical Equipment Co. , Ltd	National Arms Note 20223031769
	Coronary balloon dilation catheters	Weitai Medical Equipment (Shenzhen) Co. , Ltd	National Arms Note 20223031770
	Rigid ventilating contact lenses for orthokeratology	Shenzhen New Industry Ophthalmic New Technology Co. , Ltd	National Arms Note 20223161771
	Delivery catheter system	Beijing Jiushi Shenkang Medical Technology Co. , Ltd	National Arms Note 20223031772
	Thoracic aortic stent system	Beijing Huamai Teche Medical Equipment Co. , Ltd	National Arms Note 20223131773
	Non-absorbable band line anchors	Xiamen Delange Medical Technology Co. , Ltd	National Arms Note 20223131774
	Tibial bracket and appendages	Shanghai Ketai Maidi Medical Equipment Co. , Ltd	National Arms Note 20223131775
	Coronary hypertension predilates balloon dilation catheters	Shenzhen Yeju Industrial Co. , Ltd	National Arms Note 20223031776
	Soft hydrophilic contact lenses	ARS (Xiamen) Technology Co. , Ltd	National Arms Note 20223161777
	Microguidewire	Shanghai Likai Technology Co. , Ltd	National Arms Note 20223031778
	Neurovascular support catheter system	ContiTech (Beijing) Medical Technology Co. , Ltd	National Arms Note 20223031779
	Ankle internal fixation system	Zhuomaikang (Xiamen) Medical Equipment Co. , Ltd	National Arms Note 20223131780
	Knee femoral prosthesis	Shanghai Ketai Maidi Medical Equipment Co. , Ltd	National Arms Note 20223131781
	Individual abutments and screws	Chongqing Xinlemei Denture Co. , Ltd	National Arms Note 20223171782
	Intravascular foreign body recovery system	Shanghai Shandi Medical Technology Co. , Ltd	National Arms Note 20223031783
	Guide wire	MicroPort Longmai Medical Technology (Jiaxing) Co. , Ltd	National Arms Note 20223031784
	Dilate the catheter with a balloon under the knee	Jinan Zhengbang Medical Technology Co. , Ltd	National Arms Note 20223031785
	Non-absorbable band line anchors	Yunyi Star (Shanghai) Technology Co. , Ltd	National Arms Note 20223131786
	Cardiac surgery biological patch	Beijing Puhui Biomedical Engineering Co. , Ltd	National Arms Note 20223131787
	Metal bone needles	Beijing Bestar Biotechnology Co. , Ltd	National Arms Note 20223131788
	Dural (spine) membrane patch	Yantai Zhenghai Biotechnology Co. , Ltd	National Arms Note 20223131789
	Absorbable band wire anchors	Changchun Shengboma Biomaterials Co. , Ltd	National Arms Note 20223131790
	Non-absorbing polymer ligation clips	Fujian Newber Biotechnology Co. , Ltd	National Arms Note 20223021791
	Spinal cord stimulation doctor program-controlled charger	Changzhou Ruishenan Medical Equipment Co. , Ltd	National Arms Note 20223121792
	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Dana (Tianjin) Biotechnology Co. , Ltd	National Arms Note 20223401793
	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Beijing Bell Bioengineering Co. , Ltd	National Arms Note 20223401794
	Blood grouping and irregular antibody screening for whole blood controls	Tianjin Dexiang Biotechnology Co. , Ltd	National Arms Note 20223401795
	Permanent magnet type magnetic resonance imaging system	Luoyang Kangda Kallege Medical Technology Co. , Ltd	National Arms Note 20223061796
	Cross-match whole blood controls	Tianjin Dexiang Biotechnology Co. , Ltd	National Arms Note 20223401797
	Color Doppler ultrasound diagnostic system	Shenzhen Mindray Biomedical Electronics Co. , Ltd	National Arms Note 20223061798
	Single-use intravenous indwelling needles	Henan Camelman Medical Equipment Group Co. , Ltd	National Arms Note 20223141799
	Single-use pressure-protected extension tube	Shanghai Fuda Medical Plastics Co. , Ltd	National Arms Note 20223141800
	Soft hydrophilic contact lenses	Jiangsu Shizhun Medical Equipment Co. , Ltd	National Arms Note 20223161801
	Disposable needles for self-destructing injection pens	Beipu Medical Technology Co. , Ltd	National Arms Note 20223141802
	Single-use intravenous indwelling needles	Shandong Zhushi Pharmaceutical Group Co. , Ltd	National Arms Note 20223141803
	Can absorb hemostatic powder	Qingdao Zhongteng Biotechnology Co. , Ltd	National Arms Note 20223141804
	Single-use peripheral vascular perfusion catheter	Jiangsu Jintai Medical Equipment Co. , Ltd	National Arms Note 20223031805
	Single-use pressure precision filtration extension tube	Shanghai Fuda Medical Plastics Co. , Ltd	National Arms Note 20223141806
	Hemodialyzers	Wuhan Huacheng Chuangfu Medical Technology Co. , Ltd	National Arms Note 20223101807
	Single-use vaccine syringes	Zhejiang Lingyang Medical Equipment Co. , Ltd	National Arms Note 20223141808
	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Hangzhou Xiehe Medical Supplies Co. , Ltd	National Arms Note 20223401809
	Medical ozone machine	Shenzhen Planang Medical Technology Development Co. , Ltd	National Arms Note 20223091810
	Arthroendoscopy	Jiangsu Bangshi Medical Technology Co. , Ltd	National Arms Note 20223061811
	Motor Neuron Survival Gene 1 (SMN1) Assay Kit (PCR-Fluorescent Probe Method)	Yaneng Biotechnology (Shenzhen) Co. , Ltd	National Arms Note 20223401812
	Free Prostate-Specific Antigen (fPSA) Test Kit (Fluorescence Immunochromatography)	Key Egg Biotechnology Co. , Ltd	National Arms Note 20223401813
	X-ray computed tomography equipment	Philips Medical (Suzhou) Co. , Ltd	National Arms Note 20223061814
	Novel coronavirus (2019-nCoV) antigen detection kit (latex method)	Jiangsu Hongweites Pharmaceutical Technology Co. , Ltd	National Arms Note 20223401815
	Continuous blood purification equipment	Zhejiang Huiqin Medical Equipment Co. , Ltd	National Arms Note 20223101816
	X-ray image guidance system	Zhongke Super Precision (Nanjing) Technology Co. , Ltd	National Arms Note 20223051817
	A single nipple sphincterotomy is used	Shanghai Elton Medical Equipment Co. , Ltd	National Arms Note 20223011818
	Bipolar resection endoscopes and accessories	Chengdu Meichuang Zall Medical Technology Co. , Ltd	National Arms Note 20223061819
	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Guangdong Hexin Health Technology Co. , Ltd	National Arms Note 20223401820
	Medical angiography X-ray machine	Shanghai United Imaging Medical Technology Co. , Ltd	National Arms Note 20223061821
	Posterior spinal fixation system	Wuxi Beida Medical Technology Co. , Ltd	National Arms Note 20223131822
	Hemodialysis filters	Asahi Kasei Medical Devices (Hangzhou) Co. , Ltd	National Arms Note 20223101823
	Single-use anesthesia puncture kit	Shandong Zhushi Pharmaceutical Group Co. , Ltd	National Arms Note 20223081824
	Lamina fixation plate system	Beijing Bestar Biotechnology Co. , Ltd	National Arms Note 20223131825
	The nail rod system is fixed in the posterior circuit of the thoracolumbar spine	Ningbo Zhaoying Medical Equipment Co. , Ltd	National Arms Note 20223131826
	Disposable leukocyte removal plastic blood bags	Beijing Bode Sant Blood Transfusion Equipment Co. , Ltd	National Arms Note 20223101827
	Continuous blood purification line	Chongqing Tianwaitian Biotechnology Co. , Ltd	National Arms Note 20223101828
	Hemodialysis concentrate	Guangdong Baolaite Medical Technology Co. , Ltd	National Arms Note 20223101829
	Coronary mastoid balloon dilation ducts	Chengdu Barui Hengtong Medical Technology Co. , Ltd	National Arms Note 20223031830
	Polyetheretherketone interface screws	Jiangsu Aihopu Medical Equipment Co. , Ltd	National Arms Note 20223131831
	Positive pressure pinless connector	Beijing Tiandi Hexie Technology Co. , Ltd	National Arms Note 20223141832
	Sterile injection needles for single-use use	Taimeri (Changzhou) Medical Equipment Co. , Ltd	National Arms Note 20223141833
	Can absorb polysaccharide hemostatic powder	Suzhou Borche Tongkang Bioengineering Co. , Ltd	National Arms Note 20223141834
	Personalized abutments	Huizhou Kunpeng Denture Co. , Ltd	National Arms Note 20223171835
	Anterior cervical spine fixation plate system	Changzhou Kanghui Medical Equipment Co. , Ltd	National Arms Note 20223131836
	Hip prosthesis system components	Jingwei Medical Equipment Manufacturing (Shenzhen) Co. , Ltd	National Arms Note 20223131837
	Intervertebral fusion device	Sichuan Vista Medical Equipment Co. , Ltd	National Arms Note 20223131838
	Shoulder prosthesis	Beijing Lidakang Technology Co. , Ltd	National Arms Note 20223131839
	Internal fixation system of the posterior nail rod of the thoracolumbar spine	Shanghai Kangding Medical Equipment Co. , Ltd	National Arms Note 20223131840
	Single-room ventricular knee prosthetic system	JST Medical Equipment (Tianjin) Co. , Ltd	National Arms Note 20223131841
	Metal bone needles	Opai Mason (Jiangsu) Medical Technology Co. , Ltd	National Arms Note 20223131842
	Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)	Anhui Deep Blue Medical Technology Co. , Ltd	National Arms Note 20223401843
	Single-use pressure monitoring magnetically positioned radiofrequency ablation catheters	Shanghai MicroPort Electrophysiology Medical Technology Co. , Ltd	National Arms Note 20223011571
	Liver function shear wave quantification detector	Wuxi Hayskell Medical Technology Co. , Ltd	National Arms Note 20223071572
Imported Class III medical devices
	Microwave ablation system	Covidien llc	National weapons are injected into 20223010577
	Single-photon emission computed tomography system	Spectrum Dynamics Medical Ltd.	National weapons are injected into 20223060578
	Insulin pumps	SOOIL Development Co. , Ltd	National weapons are injected into 20223140579
	Human immunodeficiency virus antigen and antibody combination detection kit (microparticle chemiluminescence immunoassay)	Siemens Healthcare Diagnostics Inc.	National weapons are injected into 20223400582
	Anesthesia machine	MAQUET CRITICAL CARE AB	National weapons are injected into 20223080583
	Eye surgery equipment and accessories	D. O. R. C. Dutch Ophthalmic Research Center (International) B. V.	National weapons are injected into 20223160584
	Normal value hemagglutination reagent control	Instrumentation Laboratory Company	National weapons are injected into 20223400588
	Medical angiography X-ray machine	GE MEDICAL SYSTEMS SCS	National weapons are injected into 20223060589
	Radio frequency ablation meter	Biosense Webster (Israel) Ltd.	National weapons are injected into 20223010591
	Sterile injection needles for single-use use	Feel Tech Co. , Ltd.	National weapons are injected into 20223140592
	Perfusion catheters	Medos International SARL	National weapons are injected into 20223030593
	Vitrified refrigerated liquid	Vitrolife Sweden AB	National weapons are injected into 20223180594
	Peripheral vascular stents	Angiomed GmbH & Co. Medizintechnik KG	National weapons are injected into 20223130595
	Paclitaxel drug-coated peripheral balloon dilation catheter	Hemoteq AG	National weapons are injected into 20223030596
	Spring rings	Medos International SARL	National weapons are injected into 20223130597
	Auxiliary pronunciation tube	Atos Medical AB	National weapons are injected into 20223130609
	Soft hydrophilic contact lenses	CooperVision Inc.	National weapons are injected into 20223160610
	Peripheral vascular scoring balloon dilation ducts	Spectranetics Corporation	National weapons are injected into 20223030611
	Artificial shoulder joint system	DePuy (Ireland)	National weapons are injected into 20223130612
	Peripheral angiography catheters	ANGIODYNAMICS,INC.	National weapons are injected into 20223030613
	Puncture needle	Cordis Cashel	National weapons are injected into 20223030614
	Separator membrane needleless infusion connector	VYGON	National weapons are injected into 20223140615
	Needle-free closed infusion connectors	Baxter Healthcare SA	National weapons are injected into 20223140616
	Depth of focus elongated intraocular lens	Johnson & Johnson Surgical Vision, Inc.	National weapons are injected into 20223160617
	Pure titanium coated intervertebral fusion device	Medtronic Sofamor Danek USA, Inc.	National weapons are injected into 20223130618
	Negative pressure drainage material for invasive protection	KCI USA, Inc.	National weapons are injected into 20223140619
	Cochlear implants	MED-EL Elektromedizinische Geräte GmbH	National weapons are injected into 20223120620
	Implantable pacemakers	Medtronic Inc.	National weapons are injected into 20223120621
	Dehydrates the hydrogel platinum spring coil	MicroVention,Inc.	National weapons are injected into 20223130625
	Baby radiant warmer	アトムメディカル	National weapons are injected into 20223080627
	Disposable sterile injection pen with needle	Novo Nordisk A/S	National weapons are injected into 20223140628
	Microcatheter system	テルモ·クリニカルサプライ	National weapons are injected into 20223030629
	Hepatitis B virus core-associated antigen (HBcrAg) control	Fujirebio Inc.	National weapons are injected into 20223400630
	Cranial surgery positioning equipment	Medtronic Navigation, Inc.	National weapons are injected into 20223010631
	Human papillomavirus negative control	Roche Diagnostics GmbH	National weapons are injected into 20223400632
	Anchor balloon guidance extension catheter	Vascular Solutions LLC	National weapons are injected into 20223030637
	Teeth bleach	Nanova Biomaterials, Inc.	National weapons are injected into 20223170638
Imported Class II medical devices
	Fluorescence immunoassay analyzer	Response Biomedical Corporation	National weapons are injected into 20222220580
	Single-use unipolar surgical electrodes	Covidien llc	National weapons are injected into 20222010581
	Program controller	Impulse Dynamics (USA), Inc.	National weapons are injected into 20222120585
	Electronic urethral cystoscopy	KARL STORZ SE & Co. KG	National weapons are injected into 20222060586
	Soluble transferrin receptor calibrator	Roche Diagnostics GmbH	National weapons are injected into 20222400587
	Protein chip reader	Seramun Diagnostica GmbH	National weapons are injected into 20222220590
	Dental ceramics	HASS CORPORATION	National weapons are injected into 20222170598
	drill bit	Medtronic Powered Surgical Solutions	National weapons are injected into 20222040599
	Handle and accessories for electric bone tissue surgery equipment	Medtronic Powered Surgical Solutions	National weapons are injected into 20222040600
	Curved handpieces for planting	KaVo Dental GmbH	National weapons are injected into 20222170601
	Sound processor	MED-EL Elektromedizinische Geräte GmbH	National weapons are injected into 20222120602
	Laser positioning system	LAP GmbH Laser Applikationen	National weapons are injected into 20222050603
	Fully automatic chemiluminescence immunoassay analyzer	DiaSorin S. p. A.	National weapons are injected into 20222220604
	X-ray flat panel detector	キヤノンデバイス	National weapons are injected into 20222060605
	Digital mammography system	Planmed Oy	National weapons are injected into 20222060606
	Jet lag incubator	Vitrolife A/S	National weapons are injected into 20222180607
	Jet lag incubator	Vitrolife A/S	National weapons are injected into 20222180608
	Patient program controller	Medtronic Inc.	National weapons are injected into 20222120622
	Medical electric treatment bed	Dornier MedTech GmbH	National weapons are injected into 20222150623
	Single-use EEG electrodes	Covidien llc	National weapons are injected into 20222070624
	Dental X-ray machine	Osstem Implant Co. , Ltd.	National weapons are injected into 20222060626
	Visual laryngoscope	Aircraft Medical Limited	National weapons are injected into 20222080633
	Low molecular weight heparin low-value controls	HYPHEN BioMed	National weapons are injected into 20222400634
	Single-use sterilized bone grinding head	The Anspach Effort, Inc.	National weapons are injected into 20222040635
	Anti-thyroglobulin antibody controls	Siemens Healthcare Diagnostics Products Limited	National weapons are injected into 20222400636
Hong Kong, Macao and Taiwan medical devices
	Soft hydrophilic contact lenses	Falcon Technology Co. , Ltd	The national weapon is 20223160025
	Metal locking rib bone plate system	Aipex Biotechnology Co. , Ltd	National Arms Note 20223130026
	Soft hydrophilic contact lenses	Crystal Optics Co. , Ltd	National Arms Note 20223160027
	Metal bone needles	Aipex Biotechnology Co. , Ltd	The national weapon notes 20223130028

State Food and Drug Administration

January 9, 2023

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