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Medical Network March 22 hearing territory of Class III medical devices up to March 19, the State Drug Administration announced in February 2021, approved a total registered medical device product 92
.
Among them, there are 65 domestic third-class medical device products, 11 imported third-class medical device products, 15 imported second-class medical device products, and 1 Hong Kong, Macao and Taiwan medical device products (see attachment for specific products)
.
List of medical devices approved for registration in February 2021
.
Among them, there are 65 domestic third-class medical device products, 11 imported third-class medical device products, 15 imported second-class medical device products, and 1 Hong Kong, Macao and Taiwan medical device products (see attachment for specific products)
.
List of medical devices approved for registration in February 2021
Serial number | product name | Registrant name | Registration number |
---|---|---|---|
Domestic Class III medical devices |
|||
1 | Carbohydrate antigen 72-4 determination kit (direct chemiluminescence method) | Mike Biological Co. , Ltd. | National Machinery Note 20213400087 |
2 | Prostate specific antigen detection kit (magnetic particle chemiluminescence method) | Weifang Kanghua Biological Technology Co. , Ltd. | National Machinery Note 20213400088 |
3 | Carbohydrate Antigen 125 Detection Kit (Magnetic Particle Chemiluminescence Method) | Shandong Kanghua Biomedical Technology Co. , Ltd. | National Machinery Injection Standard 20113400089 |
4 | Kit for determination of alpha-fetoprotein (chemiluminescence immunoassay) | Nanjing Dignos Biotechnology Co. , Ltd. | National Machinery Note 20213400090 |
5 | Kit for determination of total prostate specific antigen (chemiluminescence immunoassay) | Nanjing Dignos Biotechnology Co. , Ltd. | National Machinery Note 20213400091 |
6 | Disposable cryoablation needle | Shanghai Guiding Medical System Co. , Ltd. | National Machinery Note Standard 20213010092 |
7 | Medical nucleic acid analyzer | Binjiang Huakang (Beijing) Biotechnology Co. , Ltd. | National Machinery Note 20213220093 |
8 | Thulium-doped fiber laser treatment machine | Shanghai Rui Keen Laser Technology Co. , Ltd. | National Machinery Note 202113010094 |
9 | Orthopedic surgery navigation and positioning system | Beijing Tianzhihang Medical Technology Co. , Ltd. | National Machinery Note 202113010095 |
10 | Magnetic resonance imaging system | Shenzhen Best Medical Co. , Ltd. | National Machinery Note 202113060096 |
11 | Continuous glucose monitoring system | Zhejiang Kailite Medical Equipment Co. , Ltd. | National Machinery Note 202113070097 |
12 | Infrared guidance tracking system | Xi'an Medical Group Co. , Ltd. | National Machinery Note 202113050098 |
13 | Ultrasound Bone Power Equipment | Beijing Shuimu Canopy Medical Equipment Co. , Ltd. | National Machinery Note 202113010099 |
14 | Novel coronavirus (2019-nCoV) IgM antibody detection kit (enzyme-linked immunoassay) | Zhuhai Livzon Reagent Co. , Ltd. | National Machinery Injection Standard 20113400100 |
15 | Novel coronavirus 2019-nCoV nucleic acid detection kit (fully integrated dish chip method) | Chengdu Boao Jingxin Biotechnology Co. , Ltd. | National Machinery Note 20213220101 |
16 | Automatic nucleic acid analyzer | Chengdu Boao Jingxin Biotechnology Co. , Ltd. | National Machinery Note 20113400102 |
17 | Single use hemodialysis machine | Guangdong Baihe Medical Technology Co. , Ltd. | National Machinery Note Standard 20213100103 |
18 | Ankle Locking Bone Plate System | Trauson Medical Devices (China) Co. , Ltd. | National Machinery Injection Standard 202113130104 |
19 | Porous vertebral body fusion cage | Hunan Huaxiang Incremental Manufacturing Co. , Ltd. | National Machinery Injection Standard 20213130105 |
20 | Single use precision filter infusion set with needle | Shandong Zhongbaokang Medical Appliance Co. , Ltd. | National Machinery Note 20213140106 |
twenty one | One-time use precision filter bag infusion set | Shandong Weigao Group Medical Polymer Products Co. , Ltd. | National Machinery Note 20213140107 |
twenty two | Non-absorbable ligament fixation screw | Beijing Ruilangtaike Medical Equipment Co. , Ltd. | National Machinery Note Standard 202113130108 |
twenty three | Disposable intravenous indwelling needle | Suzhou Linhua Medical Equipment Co. , Ltd. | National Machinery Injection Standard 20213140109 |
twenty four | Citric acid disinfectant | Shandong Lierkang Medical Technology Co. , Ltd. | National Machinery Note 20113100110 |
25 | Ankle Locking Bone Plate System | Suzhou Aide Technology Development Co. , Ltd. | National Machinery Injection Standard 202113130111 |
26 | Soft hydrophilic contact lens | Jiangsu Shizhun Medical Equipment Co. , Ltd. | National Machinery Injection Standard 20213160112 |
27 | Bacterial Cellulose Dressing | Zhende Medical Products Co. , Ltd. | National Machinery Note 20113140113 |
28 | Gastrointestinal Marker Capsules | Shanghai Anhan Medical Technology Co. , Ltd. | National Machinery Note 202113060114 |
29 | Hydrophilic Coated Contrast Catheter | Hunan Epte Medical Equipment Co. , Ltd. | National Machinery Note 202113030115 |
30 | Adjustable bending conveyor system | Lifetech Technology (Shenzhen) Co. , Ltd. | National Machinery Note 202113030116 |
31 | Metal with wire anchor | Changchun Shengbomar Biomaterials Co. , Ltd. | National Machinery Injection Standard 20113130117 |
32 | Absorbable interface screw | Beijing Tianxing Bomadi Medical Equipment Co. , Ltd. | National Machinery Injection Standard 202113130118 |
33 | Microcatheter | Nanjing Wolfman Medical Technology Co. , Ltd. | National Machinery Note 202113030119 |
34 | Hip prosthesis | Tianjin Kangernuo Technology Co. , Ltd. | National Machinery Note 20 113 130 120 |
35 | Balloon dilatation catheter | Liaoning Yinyi Biological Technology Co. , Ltd. | National Machinery Note 202113030121 |
36 | Disposable infusion set | Shandong Xinhua Ande Medical Products Co. , Ltd. | National Machinery Note 20 113140122 |
37 | Non-absorbable ligament fixation screw | Beijing Fule Technology Development Co. , Ltd. | National Machinery Injection Standard 20113130123 |
38 | Intervention guide wire | Hangzhou Dexin Medical Technology Co. , Ltd. | National Machinery Note 202113030124 |
39 | Coronary guide wire | Esun Technology (Beijing) Co. , Ltd. | National Machinery Note 202113030125 |
40 | Vertebral body expansion balloon catheter | Suzhou Sunan JMed Medical Equipment Co. , Ltd. | National Machinery Note 202113040126 |
41 | Self-stabilizing anterior cervical interbody fusion fixation system | Beijing Fule Technology Development Co. , Ltd. | National Machinery Note 20 113130127 |
42 | Hip joint prosthesis ceramic ball head | Beijing Lidakang Technology Co. , Ltd. | National Machinery Note 20 113130128 |
43 | Electronic upper gastrointestinal endoscope | Shanghai Siyao Medical Devices Co. , Ltd. | National Machinery Note 202113060129 |
44 | Radiotherapy image guidance system | Shandong Xinhua Medical Equipment Co. , Ltd. | National Machinery Note 202113050130 |
45 | Spine surgery navigation and positioning system | Shenzhen Xinjunte Intelligent Medical Equipment Co. , Ltd. | National Machinery Note 202113010131 |
46 | X-ray computed tomography system | Zhejiang Longrun Medical Technology Co. , Ltd. | National Machinery Note 202113060132 |
47 | Patient monitor | Shenzhen Keman Medical Equipment Co. , Ltd. | National Machinery Note 202113070133 |
48 | Magnetic resonance imaging system | General Electric Medical System (Tianjin) Co. , Ltd. | National Machinery Note 202113060134 |
49 | Single use electric snare | Jiangsu Gelite Medical Technology Co. , Ltd. | National Machinery Note 202113010135 |
50 | X-ray computed tomography equipment | Wuhan United Imaging Medical Technology Co. , Ltd. | National Machinery Note 202113060136 |
51 | EB virus nuclear antigen IgA antibody detection kit (enzyme-linked immunosorbent assay) | Avic Biotechnology Co. , Ltd. | National Machinery Note 20113400137 |
52 | HER2 gene detection kit (fluorescence in situ hybridization method) | Guangzhou Anbiping Pharmaceutical Technology Co. , Ltd. | National Machinery Note 20113400138 |
53 | EB virus capsid antigen IgM antibody detection kit (enzyme-linked immunosorbent assay) | Avic Biotechnology Co. , Ltd. | National Machinery Note 20113400139 |
54 | Tumor Marker Substance Control I | Dirui Medical Technology Co. , Ltd. | National Machinery Note 20113400140 |
55 | Human epididymal protein 4 (HE4) determination kit (magnetic particle chemiluminescence method) | Jiangsu Zecheng Biotechnology Co. , Ltd. | National Machinery Note 20113400141 |
56 | Gastrin releasing peptide precursor detection kit (magnetic particle chemiluminescence method) | Taizhou Zecheng Biotechnology Co. , Ltd. | National Machinery Note 20113400142 |
57 | Cancer antigen CA72-4 determination kit (magnetic particle chemiluminescence immunoassay) | Beijing Huizhong Medical Devices Co. , Ltd. | National Machinery Note 20113400143 |
58 | Squamous Cell Carcinoma Antigen (SCC) Assay Kit (Magnetic Particle Chemiluminescence Immunoassay) | Beijing Huizhong Medical Devices Co. , Ltd. | National Machinery Note 20113400144 |
59 | Hepatitis B virus (HBV) nucleic acid detection kit (fluorescence PCR method) | Guangzhou Baochuang Biotechnology Co. , Ltd. | National Machinery Note 20113400145 |
60 | Neuron specific enolase (NSE) assay kit (magnetic particle chemiluminescence method) | Shandong Kanghua Biomedical Technology Co. , Ltd. | National Machinery Note 20113400146 |
61 | Cancer antigen 72-4 (CA72-4) determination kit (magnetic particle chemiluminescence method) | Shandong Kanghua Biomedical Technology Co. , Ltd. | National Machinery Note 20113400147 |
62 | Carbohydrate Antigen 50 (CA50) Determination Kit (Magnetic Particle Chemiluminescence Method) | Shandong Kanghua Biomedical Technology Co. , Ltd. | National Machinery Note 20113400148 |
63 | Tumor-associated antigen 15-3 determination kit (chemiluminescence immunoassay) | Suzhou Changguanghua Doctor Biomedical Engineering Co. , Ltd. | National Machinery Note 20113400149 |
64 | ABO blood group antigen test card (microcolumn gel method) | Shenzhen Akcome Reagent Co. , Ltd. | National Machinery Injection Standard 20113400150 |
65 | Human KRAS/NRAS/BRAF/PIK3CA gene mutation joint detection kit (reversible terminal termination sequencing method) | Zhenyue Biological Technology Jiangsu Co. , Ltd. | National Machinery Note 20113400151 |
Imported third-class medical devices |
|||
66 | Single use high frequency mucosal incision knife | Orinbes Meadows Co. , Ltd. | National Machinery Injection into 20213010035 |
67 | Magnetic resonance guided focused ultrasound therapy system | InSightec, Ltd. | National Machinery Injection into 20213010036 |
68 | Digital mammography system | IMS GIOTTO SpA | National Machinery Injection into 20213060037 |
69 | X-ray computed tomography equipment | Siemens Healthcare GmbH | National Machinery Injection into 20213060038 |
70 | Soft hydrophilic contact lens | CooperVision Inc. | National Machinery Injection 20113160047 |
71 | Soft hydrophilic contact lens | CooperVision Inc. | National Machinery Injection 20113160048 |
72 | Selective melting of cobalt-chromium alloy powder by dental laser | BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | National Machinery Injection 20213170049 |
73 | Calcium Alginate Dressing | Lohmann & Rauscher International GmbH & Co. KG | National Machinery Injection 20213140050 |
74 | Autologous blood recovery machine | Medtronic Inc. | National Machinery Injection 20113100054 |
75 | Patient placement verification device | C-RAD Positioning AB | National Machinery Injection into 20213050055 |
76 | Positron emission and X-ray computed tomography system | GE Medical System, LLC | National Machinery Injection into 20213060056 |
Imported second-class medical devices |
|||
77 | Common liver quality control products | Roche Diagnostics GmbH | National Machinery Injection 20122400031 |
78 | B-type natriuretic peptide detection kit (immunochromatographic method) | Sekisui Medakal Co. , Ltd. | National Machinery Injection 20122400032 |
79 | Lupus Anticoagulant Control Substance | Roche Diagnostics GmbH | National Machinery Injection 20122400033 |
80 | High-sensitivity troponin I determination kit (chemiluminescence method) | Ortho-Clinical Diagnostics | National Machinery Injection 20122400034 |
81 | Blood Pressure Monitor | InBody Co. , Ltd. | National Machinery Injection into 20212070039 |
82 | Heated breathing circuit for single use | TNI medical AG | National Machinery Injection into 20212080040 |
83 | Cold air therapy device | Zimmer MedizinSysteme GmbH | National Machinery Injection into 20212090041 |
84 | Dental implant machine | Dentium Co. ,Ltd. | National Machinery Injection into 202212170042 |
85 | Dental handpiece | Kaltenbach & Voigt GmbH | National Machinery Injection into 202212170043 |
86 | Sound processor | MED-EL Elektromedizinische Geräte GmbH | National Machinery Injection into 20212120044 |
87 | Muscle function appliance | ORTHOPLUS SAS | National Machinery Injection into 202212170045 |
88 | Tip cap for disposable endoscope | Fujifilm Corporation | National Machinery Injection into 20212060046 |
89 | Zirconia block for all-ceramic denture | DOCERAM Medical Ceramics GmbH | National Machinery Injection into 202212170051 |
90 | Arthroscopy surgical instruments | Cayenne Medical, Inc. | National Machinery Injection into 20212040052 |
91 | Intraocular lens implant system | Yilmaz Medikal-Mustafa Nazlier | National Machinery Injection 20212160053 |
Hong Kong, Macao and Taiwan medical equipment |
|||
92 | Soft hydrophilic contact lens | Xingou Optical Co. , Ltd. | National Machinery Note 20213160002 |