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Announcement of the State Food and Drug Administration on the approval and registration of 204 medical device products

 Last Update: 2022-11-26
 Source: Internet
 Author: User

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In October 2022, the State Medical Products Administration approved a total of 204 registered medical device products
.
Among them, there are 146 domestic Class III medical device products, 34 imported Class III medical device products, 23 imported Class II medical device products, and 1 Hong Kong, Macao and Taiwan medical device products (see Annex for specific products).

This is hereby announced
.
Attachment: The catalogue of medical devices was approved for registration in October 2022

serial number	Product name	Name of the registrant	Certificate number
Domestic Class III medical devices
1	Internal fixation system of the posterior nail rod of the thoracolumbar spine	Xiamen Zhongkexing Medical Equipment Co. , Ltd	National Arms Note 20223131305
2	Internal fixation system of the spine	Medtronic (Shanghai) Management Co. , Ltd	National Arms Note 20223131306
3	Craniomaxillofacial internal fixing screws	Shanghai Wujian Medical Equipment Co. , Ltd	National Arms Note 20223131307
4	Metal bone needles	Beijing Chunli Zhengda Medical Equipment Co. , Ltd	National Arms Note 20223131308
5	With loop titanium plate	Shanghai Sanyou Medical Equipment Co. , Ltd	National Arms Note 20223131309
6	Intervertebral fusion device	Beijing Zhongan Taihua Technology Co. , Ltd	National Arms Note 20223131310
7	Laser selective melting of cobalt-chromium alloy powder in dentistry	Dongguan Xiangtong Optoelectronic Technology Co. , Ltd	National Arms Note 20223171311
8	With loop fixing plate	Shandong Weigao Orthopedic Materials Co. , Ltd	National Arms Approval 20223131312
9	Drug-coated coronary balloon catheters	Sichuan Xingtai Pule Medical Technology Co. , Ltd	National Arms Note 20223031313
10	Skull fixation system	Guangdong Steibao Medical Technology Co. , Ltd	National weapons are approved 20223131314
11	Single-use hemodialysis tubing	Bain Medical Equipment (Guangzhou) Co. , Ltd	National Arms Note 20223101315
12	It can cut abutment posts and screws	Guangdong Weiliming Technology Co. , Ltd	National Arms Note 20223171316
13	Neurovascular microcatheters	Shenzhen Shunmei Medical Co. , Ltd	National Arms Note 20223031317
14	Posterior spinal fixation system	Shuojue (Jiangsu) Medical Technology Co. , Ltd	National Arms Note 20223131318
15	Carotid balloon dilation catheter	Pugao Medical Technology (Nanjing) Co. , Ltd	National Arms Note 20223031319
16	Individual abutments and screws	Shandong Meier Medical Technology Co. , Ltd	National weapons are approved 20223171320
17	Single-use light-protected IV nutrition infusion bags	Jiangsu Kangjin Medical Equipment Co. , Ltd	National Arms Note 20223141321
18	Disposable endoscopic injection needles	Jiangsu Kangjin Medical Equipment Co. , Ltd	National weapons are approved 20223141322
19	Individual abutments and screws	Guangdong Weiliming Technology Co. , Ltd	National Arms Note 20223171323
20	ulnar radius with clavicle intramedullary nail system	Xiamen Delange Medical Technology Co. , Ltd	National Arms Note 20223131324
21	Peripheral balloon dilation catheter	Jianyuan Medical Technology (Wuxi) Co. , Ltd	National Arms Note 20223031325
22	Guide sheath group	Guangdong Bomai Medical Technology Co. , Ltd	National Arms Note 20223131326
23	Single-use micropump front tube	Zhejiang Haisheng Medical Equipment Co. , Ltd	National Arms Note 20223141327
24	Extend the catheter	Sino Medical Science and Technology Co. , Ltd	National Arms Note 20223031328
25	With loop titanium plate	Yunyi Star (Shanghai) Technology Co. , Ltd	National Arms Note 20223131329
26	Coronary overall exchange balloon dilation duct	Dingke Medical Technology (Suzhou) Co. , Ltd	National Arms Note 20223031330
27	Single-use high-pressure contrast syringes and accessories	Shenzhen Kaifumai Medical Technology Co. , Ltd	National Arms Note 20223061331
28	Hydrophobic acrylate aspheric intraocular lens	Xi'an Eyedela Medical Technology Co. , Ltd	National Arms Note 20223161332
29	Citric acid disinfectant	Jiangsu Nahai Biotechnology Co. , Ltd	National Arms Note 20223101333
30	Active biological bone	Yantai Zhenghai Biotechnology Co. , Ltd	National Arms Note 20223131334
31	X-ray computed tomography equipment	Mingfeng Medical Systems Co. , Ltd	National Arms Note 20223061335
32	Oral and maxillofacial conical beam computed tomography equipment	Suzhou Qiying Medical Technology Co. , Ltd	National Arms Note 20223061336
33	Angiography X-ray machine	Ningbo Kangda Kaineng Medical Technology Co. , Ltd	National Arms Note 20223061337
34	Insulin pumps	Zhengzhou Ruiyu Technology Co. , Ltd	National Arms Note 20223141338
35	Free Prostate-Specific Antigen (fPSA) Assay Kit (Magnetic Particulate Chemiluminescence Immunoassay)	Beijing Tiger Kexin Biotechnology Co. , Ltd	National Arms Note 20223401339
36	X-ray computed tomography equipment	Ningbo Kangda Kaineng Medical Technology Co. , Ltd	National Arms Note 20223061340
37	Medical magnetic resonance imaging system	Philips Medical (Suzhou) Co. , Ltd	National Arms Note 20223061341
38	Medical angiography X-ray machine	Siemens (Shenzhen) Magnetic Resonance Co. , Ltd	National Arms Note 20223061342
39	Ophthalmic intense pulsed light therapy device	Shanxi Ruihao Biotechnology Co. , Ltd	National Arms Note 20223161343
40	High-frequency surgical equipment	Chongqing Xishan Technology Co. , Ltd	National Arms Note 20223011344
41	Single-use electric snares	Jiangxi Zhuoruihua Medical Equipment Co. , Ltd	National Arms Note 20223011345
42	Intracranial aneurysm surgery planning software	Qianglian Zhichuang (Beijing) Technology Co. , Ltd	National Arms Note 20223211346
43	Single-use electric snares	Suzhou Frankman Medical Equipment Co. , Ltd	National Arms Note 20223011347
44	Microwave ablation system	Nanjing Yigao Microwave System Engineering Co. , Ltd	National Arms Note 20223011348
45	Total Prostate-Specific Antigen (tPSA) Assay Kit (Electrochemiluminescence)	Shenzhen Pumen Technology Co. , Ltd	National Arms Note 20223401349
46	Free Prostate-Specific Antigen (fPSA) Assay Kit (Electrochemiluminescence)	Shenzhen Pumen Technology Co. , Ltd	National Arms Note 20223401350
47	Alpha-fetoprotein (AFP) assay kit (electrochemiluminescence)	Shenzhen Pumen Technology Co. , Ltd	National Arms Note 20223401351
48	X-ray computed tomography equipment	Philips Medical (Suzhou) Co. , Ltd	National Arms Note 20223061352
49	Medical angiography X-ray machine	Beijing GE Hualun Medical Equipment Co. , Ltd	National Arms Note 20223061353
50	Oral and maxillofacial conical beam computed tomography equipment	Youfang (Hefei) Medical Technology Co. , Ltd	National Arms Note 20223061354
51	Absorbable silk repair membrane	Hubei Sairo Biomaterials Co. , Ltd	National Arms Note 20223171355
52	Individual abutments and screws	Chongqing Xikema Medical Equipment Co. , Ltd	National Arms Note 20223171356
53	Dental laser selectivity melts cobalt-chromium alloy powder	Panxing New Alloy Materials (Changzhou) Co. , Ltd	National Arms Note 20223171357
54	Sperm wash	Ruibai Biotech (China) Co. , Ltd	National Arms Note 20223181358
55	It can cut abutment posts and screws	Shandong Meier Medical Technology Co. , Ltd	National Arms Note 20223171359
56	Single-use precision filtration infusion with needles	Jiakang Medical Equipment (Qingdao) Co. , Ltd	National Arms Note 20223141360
57	Peripheral balloon dilation catheter	Jinan Zhengbang Medical Technology Co. , Ltd	National Arms Note 20223031361
58	Catheter sheath assembly	Ditai Medical Technology (Suzhou) Co. , Ltd	National Arms Note 20223031362
59	Single-use anti-needle sterile syringe with needle	Shandong Weigao Group Medical Polymer Products Co. , Ltd	National Arms Note 20223141363
60	Single-use anti-needle venous indwelling needles	Shandong Ande Medical Supplies Co. , Ltd	National Arms Note 20223141364
61	Coagulation calibrator	Shenzhen Meketian Biomedical Technology Co. , Ltd	National Arms Note 20223401365
62	Mycoplasma pneumoniae nucleic acid detection kit (PCR-fluorescent probe method)	Shenzhen Yicube Biotechnology Co. , Ltd	National Arms Note 20223401366
63	Mycobacterium tuberculosis and rifampicin resistance mutation detection kit (PCR-fluorescent probe method)	Suzhou Chuanglan Biotechnology Co. , Ltd	National Arms Note 20223401367
64	Free prostate-specific antigen detection kit (chemiluminescence)	Nanjing Norman Biotechnology Co. , Ltd	National Arms Note 20223401368
65	Real-time PCR analyzer	Beijing Jinhao Pharmaceutical Co. , Ltd	National Arms Note 20223221369
66	Human MTHFR gene polymorphism detection kit (fluorescent PCR method)	Wuhan Kadevis Biotechnology Co. , Ltd	National Arms Note 20223401370
67	Septin9/SDC2/BCAT1 Gene Methylation Detection Kit (PCR-Fluorescent Probe Method)	Beijing Aiklen Medical Technology Co. , Ltd	National Arms Note 20223401371
68	X-ray computed tomography equipment	Suzhou Boying Medical Technology Co. , Ltd	National Arms Note 20223061372
69	X-ray computed tomography equipment	Shanghai United Imaging Medical Technology Co. , Ltd	National Arms Note 20223061373
70	Tuberculosis X-ray image-assisted evaluation software	Jiangxi Zhongke Jiufeng Intelligent Medical Technology Co. , Ltd	National Arms Note 20223211374
71	Single-use star magnetoelectric positioning mapping catheter	Shanghai MicroPort Electrophysiology Medical Technology Co. , Ltd	National Arms Note 20223071375
72	Benzodiazepine detection kit (colloidal gold immunochromatography)	Shenzhen Yirui Biotechnology Co. , Ltd	National Arms Note 20223401376
73	Single-use laparoscopic high-frequency surgical electrodes	Hangzhou Guangdian Medical Equipment Co. , Ltd	National Arms Note 20223011377
74	Sterile injection needles for single-use use	Beijing Aerospace Cardi Technology Development Institute	National Arms Note 20223141378
75	Artificial hip prosthesis Ceramic ball head	Shandong Weigao Starfish Medical Equipment Co. , Ltd	National Arms Note 20223131379
76	Metal locking nail plate system	Jiangsu Baiyide Medical Technology Co. , Ltd	National Arms Note 20223131380
77	Pre-filled catheter irrigator	Xuzhou Fifth Pharmaceutical Factory Co. , Ltd	National Arms Note 20223141381
78	Single-use non-absorbable closure clip	Jiangsu Songze Medical Technology Co. , Ltd	National Arms Note 20223021382
79	Vertebral body dilation balloon catheter	Ningbo Zhaoying Medical Equipment Co. , Ltd	National Arms Note 20223041383
80	Single-use pressure connection pipe	Shenzhen Leningkang Medical Technology Co. , Ltd	National Arms Note 20223061384
81	Anterior cervical spine fixation plate system	Medtronic (Shanghai) Management Co. , Ltd	National Arms Note 20223131385
82	Gastrointestinal marker capsules	Shanghai Anhan Medical Technology Co. , Ltd	National Arms Note 20223061386
83	Hemodialyzers	Suzhou Zhuoyi Medical Equipment Co. , Ltd	National Arms Note 20223101387
84	Internal fixation system of the spine	Linke Medical Equipment (Chongqing) Co. , Ltd	National Arms Note 20223131388
85	Individual abutments and screws	Zhengzhou Sanhe denture production Co. , Ltd	National Arms Note 20223171389
86	Single-use pressure extension tube	Shenzhen Yixinda Medical New Technology Co. , Ltd	National Arms Note 20223031390
87	Door type nails	Beijing Keyi Bonn Medical Device Technology Co. , Ltd	National Arms Note 20223131391
88	Blood flow directs to the mesh stent	Eco Medical Devices (Beijing) Co. , Ltd	National Arms Note 20223131392
89	Distal access catheter	Suzhou Zhongtian Medical Device Technology Co. , Ltd	National Arms Note 20223031393
90	Neurovascular microcatheters	Juhui Medical Technology (Shenzhen) Co. , Ltd	National Arms Note 20223031394
91	Oral titanium membrane and accessories	Wuxi Lingdi Biotechnology Co. , Ltd	National Arms Note 20223171395
92	Intracranial balloon dilation catheter	Jiangsu Nuanyang Medical Equipment Co. , Ltd	National Arms Note 20223031396
93	Microcatheter system	Shenzhen Macpuge Medical Technology Co. , Ltd	National Arms Note 20223031397
94	Delivery assisted microcatheters	Suzhou Zhongtian Medical Device Technology Co. , Ltd	National Arms Note 20223031398
95	Metal cable system	Tianjin Weiman Biomaterials Co. , Ltd	National Arms Note 20223131399
96	Dura (spine) membrane biological patch	Tianjin Orke Pharmaceutical Technology Co. , Ltd	National Arms Note 20223131400
97	Metal bone needles	Ningbo Zhaoying Medical Equipment Co. , Ltd	National Arms Note 20223131401
98	Guide tube	Nanjing Kangyou Medical Technology Co. , Ltd	National Arms Note 20223031402
99	Single-use anti-needle venous indwelling needles	Yangpu Medical (Hunan) Co. , Ltd	National Arms Note 20223141403
100	Single-use self-destructing fixed-dose vaccine syringe with needle	Shandong Xinhua Ande Medical Supplies Co. , Ltd	National Arms Note 20223141404
101	Dialysate filter	Bain Medical Equipment (Guangzhou) Co. , Ltd	National Arms Note 20223101405
102	Intervertebral fusion device	Shandong Xinhua United Orthopedic Equipment Co. , Ltd	National Arms Note 20223131406
103	Sperm cryography	Ruibai Biotech (China) Co. , Ltd	National Arms Note 20223181407
104	Metal bone needles	Shandong Kangsheng Medical Equipment Co. , Ltd	National Arms Note 20223131408
105	Single-use microporous filtration infusion apparatus with needle	Henan Camel Sanrui Medical Equipment Co. , Ltd	National Arms Note 20223141409
106	Infusion lines for single-use insulin pumps	Zhengzhou Ruiyu Technology Co. , Ltd	National Arms Note 20223141410
107	Single-use IV nutrition infusion bags	Rena Kangde Medical Technology (Tianjin) Co. , Ltd	National Arms Note 20223141411
108	Single-use insulin pump with a drug reservoir	Zhengzhou Ruiyu Technology Co. , Ltd	National Arms Note 20223141412
109	Rigid breathable contact lenses	Tianjin Century Kangtai Biomedical Engineering Co. , Ltd	National Arms Note 20223161413
110	Rigid contact lenses	Hangzhou Bochton Optical Co. , Ltd	National Arms Note 20223161414
111	Occipital-cervicothoracic spinal posterior fixation system	Chongqing Fuworth Medical Equipment Co. , Ltd	National Arms Note 20223131415
112	Metal bone needles	Suzhou Ubet Medical Equipment Co. , Ltd	National Arms Note 20223131416
113	Minimally invasive locking hollow bone screws	Shandong Kangsheng Medical Equipment Co. , Ltd	National Arms Note 20223131417
114	Coronary balloon dilation catheters	Anjit (Tianjin) Technology Co. , Ltd	National Arms Note 20223031418
115	Mycobacterial identification kit (fluorescent PCR melting curve method)	Xiamen Zhishan Biotechnology Co. , Ltd	National Arms Note 20223401419
116	Human metapneumovirus nucleic acid detection kit (PCR-fluorescent probe method)	Zhengzhou Antu Bioengineering Co. , Ltd	National Arms Note 20223401420
117	Influenza A virus/influenza B virus/respiratory syncytial virus nucleic acid detection kit (PCR-fluorescent probe method)	Zhengzhou Antu Bioengineering Co. , Ltd	National Arms Note 20223401421
118	Color ultrasound diagnostic instrument	GE Medical Systems (China) Co. , Ltd	National Arms Note 20223061422
119	Chromosomal aneuploidy detection kit (combined probe-anchored polymerization sequencing)	BGI Biotechnology (Wuhan) Co. , Ltd	National Arms Note 20223401423
120	Herpes simplex virus type I IgG antibody (HSV-I IgG) test kit (chemiluminescence immunoassay)	Guangzhou Kangrun Biotechnology Co. , Ltd	National Arms Note 20223401424
121	Single-use sterile temperature sensor	Hijaya (Beijing) Medical Equipment Co. , Ltd	National Arms Note 20223011425
122	ECG analysis software	Xiamen Nalong Health Technology Co. , Ltd	National Arms Note 20223211426
123	Medical magnetic resonance imaging system	General Electric Medical Systems (Tianjin) Co. , Ltd	National Arms Note 20223061427
124	Electric insulin syringe	Kailian Medical Technology (Shanghai) Co. , Ltd	National Arms Note 20223141428
125	Medical magnetic resonance imaging system	General Electric Medical Systems (Tianjin) Co. , Ltd	National Arms Note 20223061429
126	X-ray computed tomography equipment	Aerovade General Electric Medical Systems Co. , Ltd	National Arms Note 20223061430
127	Fully automatic blood group analyzer	Suzhou Suda Xaier Immunobiotechnology Co. , Ltd	National Arms Note 20223221431
128	Human EGFR/ALK/ROS1 Gene Mutation Combined Detection Kit (Fluorescent PCR Method)	Guangzhou Maijing Gene Medical Technology Co. , Ltd	National Arms Note 20223401432
129	Group B streptococcal nucleic acid detection kit (isothermal amplification chip method)	Shanghai Suchuang Diagnostic Products Co. , Ltd	National Arms Note 20223401433
130	Human leukocyte antigen B locus 5801 gene detection kit (PCR-fluorescent probe method)	Wuhan Youzhiyou Medical Technology Co. , Ltd	National Arms Note 20223401434
131	Metal strip wire anchors	Hangzhou Ruijian Masten Medical Equipment Co. , Ltd	National Arms Note 20223131435
132	U-studs	Tianjin Liyuan Medical Technology Co. , Ltd	National Arms Note 20223131436
133	Titanium alloy with wire anchors	Ningbo Zhaoying Medical Equipment Co. , Ltd	National Arms Note 20223131437
134	Autostabilizing anterior cervical intervertebral fusion fixation system	Changzhou Jishuo Medical Equipment Co. , Ltd	National Arms Note 20223131438
135	Noncompliant balloon dilation catheters	Sino Medical Science and Technology Co. , Ltd	National Arms Note 20223031439
136	Aspheric diffraction multifocal intraocular lenses	Aibonord (Beijing) Medical Technology Co. , Ltd	National Arms Note 20223161440
137	Heparin caps for infusions	Suzhou Xinkang Dao Medical Technology Co. , Ltd	National Arms Note 20223141441
138	Single-use high-pressure contrast syringes and accessories	Shenzhen Yixinda Medical New Technology Co. , Ltd	National Arms Note 20223061442
139	Hemodialysis powder	Jiangxi Sanxin Medical Technology Co. , Ltd	National Arms Note 20223101443
140	Disinfectant caps for disposable infusion connectors	Beijing Tiandi Hexie Technology Co. , Ltd	National Arms Note 20223031444
141	Single-use hemodialyzers	Zhuhai Jianhang Medical Technology Co. , Ltd	National Arms Note 20223101445
142	One-time use of a human arterial blood sample	Henan Camel Medical Technology Co. , Ltd	National Arms Note 20223221446
143	Single-use microporous filtration infusion apparatus with needle	Henan Camel Sanrui Medical Equipment Co. , Ltd	National Arms Note 20223141447
144	Guide wire	Foshan Qiyou Medical Technology Co. , Ltd	National Arms Note 20223031448
145	Citric acid disinfectant	Tianjin Standard Biologics Co. , Ltd	National Arms Note 20223101449
146	Single-use extracranial drainage kit	Shandong Taizheng Medical Equipment Co. , Ltd	National Arms Note 20223141450
Imported Class III medical devices
147	Light-curing composite resin	ジーシーデンタルプロダクツ	National weapons are injected into 20223170469
148	Central venous catheters for hemodialysis	Covidien llc	National weapons are injected into 20223100470
149	Thrombus suction catheter	Medos International SARL	National weapons are injected into 20223030471
150	Implantable nerve stimulation test electrodes	St. Jude Medical	National weapons are injected into 20223120472
151	Ophthalmic ultrasound lens removal and vitrectomy equipment	Fritz Ruck Ophthalmologische Systeme GmbH	National weapons are injected into 20223160473
152	Coagulation controls	Roche Diagnostics GmbH	National weapons are injected into 20223400474
153	Intra-aortic balloon catheters and appendages	datascope Corp.	National weapons are injected into 20223030475
154	Human immunodeficiency virus antigen and antibody combined detection control	Ortho-Clinical Diagnostics	National weapons are injected into 20223400481
155	Deep intracranial electrodes	PMT Corporation	National weapons are injected into 20223070482
156	Corneal crosslinker	Iromed Group S. r. l.	National weapons are injected into 20223160483
157	Body cavity heat perfusion therapy machine	RanD S. p. A.	National weapons are injected into 20223090484
158	Electronic ureteral renal endoscope and accessories	Richard Wolf GmbH	National weapons are injected into 20223060485
159	Ultrasound diagnostic instrument	SAMSUNG MEDISON CO. , LTD.	National weapons are injected into 20223060486
160	Microwave therapy instrument		National weapons are injected into 20223090487
161	Patent ductus arteriosus closure device	Abbott Medical	National weapons are injected into 20223130492
162	Paque spine with bone cement	G21 S. r. l.	National weapons are injected into 20223130493
163	Patent ductus arteriosus closure device small delivery catheter	Abbott Medical	National weapons are injected into 20223030499
164	Anti-embolic brain protection device	Boston Scientific Corporation	National weapons are injected into 20223030500
165	Cross-linked sodium hyaluronate gel for injection	Fine Bio Co. , Ltd	National weapons are injected into 20223130501
166	One-piece toroidal intraocular lens	Johnson & Johnson Surgical Vision, Inc.	National weapons are injected into 20223160502
167	Blood flow directs to the mesh stent	Stryker Neurovascular	National weapons are injected into 20223130503
168	Plasmapheresis tubing	Fresenius Medical Care AG & Co. KGaA	National weapons are injected into 20223100504
169	Vascular suture closure device	Abbott Vascular	National weapons are injected into 20223020505
170	Contact lens lubricant	SANTEN	National weapons are injected into 20223160506
171	Microcatheters	BALT EXTRUSION SAS	National weapons are injected into 20223030507
172	Light-curing adhesives	SPIDENT Co. , Ltd.	National weapons are injected into 20223170515
173	Soft hydrophilic contact lenses	Visco Technology Sdn. Bhd.	National weapons are injected into 20223160516
174	Single-use ring mapping catheters	Biosense Webster, Inc.	National weapons are injected into 20223070517
175	Coagulation calibrator	Instrumentation Laboratory Company	National weapons are injected into 20223400518
176	Catheter sheath	Boston Scientific Corporation	National weapons are injected into 20223030520
177	Hip system component – acetabular lining	Howmedica Osteonics Corp.	National weapons are injected into 20223130521
178	Double layer artificial leather repair material	グンゼ	National weapons are injected into 20223130522
179	Small bowel feeding tubes	Fresenius Kabi AG	National weapons are injected into 20223140523
180	Single-use cardiopulmonary diversion system centrifugal pump head	Medos Medizintechnik AG	National weapons are injected into 20223100524
Imported Class II medical devices
181	X-ray flat panel detector	キヤノンデバイス	National weapons are injected into 20222060476
182	Electrodes for blood gas detection	Nova Biomedical Corporation	National weapons are injected into 20222220477
183	Endoscopic camera equipment	GIMMI GmbH	National weapons are injected into 20222060478
184	Perfusion pump	Biosense Webster(Israel)Ltd.	National weapons are injected into 20222010479
185	Three-dimensional thoracic and abdominal endoscope and accessories	Aesculap AG	National weapons are injected into 20222060480
186	Intense pulsed light therapy device	CyDen Ltd	National weapons are injected into 20222090488
187	ECG tester	Vyaire Medical GmbH	National weapons are injected into 20222070489
188	Surgical power system	adeor Medical AG	National weapons are injected into 20222010490
189	Vital signs detector	Welch Allyn, Inc.	National weapons are injected into 20222070491
190	Breast tryouts	Mentor	National weapons are injected into 20222020494
191	Seawater nasal sprayer	Jadran-Galenski laboratorij d. d.	National weapons are injected into 20222140495
192	Single-use sterilized rubber surgical gloves	Careglove Global Sdn. Bhd.	National weapons are injected into 20222140496
193	Dental implant drills	ORNAGHI LUIGI & C. S. n. c.	National weapons are injected into 20222170497
194	Dyeing solution for all-ceramic dentures	Genoss Co. , Ltd.	National weapons are injected into 20222170498
195	25-Hydroxyvitamin D Assay Kit (Chemiluminescence)	Immunodiagnostic Systems Limited	National weapons are injected into 20222400508
196	Beam scanning measurement system	PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH	National weapons are injected into 20222050509
197	Laser positioning system	LAP GmbH Laser Applikationen	National weapons are injected into 20222050510
198	Oral digital impression machine	Sirona Dental Systems GmbH	National weapons are injected into 20222170511
199	Ventilators	Breas Medical AB	National weapons are injected into 20222080512
200	Gastrin Releasing Peptide Precursor (ProGRP) Assay Kit (Chemiluminescence)	Fujirebio Inc.	National weapons are injected into 20222400513
201	Composite quality controls	Roche Diagnostics GmbH	National weapons are injected into 20222400514
202	Orthopedic surgical instrument package for endoscopy	Arthrex,Inc.	National weapons are injected into 20222040519
203	Dental zirconia porcelain blocks	3M Deutschland GmbH	National weapons are injected into 20222170525
Hong Kong, Macao and Taiwan medical devices
204	Aerostomy cannula	Yiren International Medical Equipment Co. , Ltd	The national weapon is 20222080024

State Food and Drug Administration November 9, 2022

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