NMPA Approved 135 Medical Devices in May 2020

2020-06-29

On May 19, 2020, NMPA has approved a total of 135 medical devices. 79 of them are domestic Class III medical devices, 21 of them are imported Class III medical devices, 32 of them are imported Class II medical devices and 3 of them are from Hong Kong, Macao and Taiwan.

Link: http://www.nmpa.gov.cn/WS04/CL2121/378280.html

Please find the approved imported medical devices in May2020 as below. If you want to know

more about your device category, clinical pathways, predicate information and other related to

your China business, please do not hesitate to contact us at info@chinameddevice.cn.

Approved Imported Medical Devices in April 2020

No.

Product Name

Registrant Name

Certificate Number

Imported Class III Medical Devices
1.	VENTANA PD-L1（SP263）Assay	Ventana Medical Systems, Inc.	国械注进20203400245
2.	Monoclonal Mouse Anti-Human PD-L1 Clone 22C3	Dako Denmark A/S	国械注进20203400246
3.	Two Channel 3D Endoscope & Accessory	SCHÖLLY FIBEROPTIC GMBH	国械注进20203060247
4.	Video endoscope	富士フイルム株式会社	国械注进20203060248
5.	Vectris Spinal Cord Stimulation Trialing Lead	Medtronic Inc.	国械注进20203120262
6.	Video endoscope	富士フイルム株式会社	国械注进20203060263
7.	Magnetic Resonance Equipment	Philips Medical Systems Nederland B.V.	国械注进20203060264
8.	Q-Switched Nd: YAG Laser System	원텍（주）	国械注进20203090265
9.	Video endoscope	富士フイルム株式会社	国械注进20203060266
10.	Video endoscope	富士フイルム株式会社	国械注进20203060267
11.	Medical Angiography X-ray System	Philips Medical Systems Nederland B.V.	国械注进20203060268
12.	NOVOTTF-100A: Tumor Treating Fields Instrument	NovoCure Ltd.	国械注进20203090269
13.	Soft Hydrophilic Contact Lens	CooperVision Inc.	国械注进20203160258
14.	Universal Adhesive	DENTSPLY DeTrey GmbH	国械注进20203170259
15.	AMPLATZER Amulet Left Atrial Appendage Occluder	St. Jude Medical Coordination Center BVBA	国械注进20203130260
16.	Soft Contact lens	Bausch & Lomb Incorporated	国械注进20203160261
17.	Teeth Whitening Gel	HS SCIENCE AND TECHNOLOGY INC.	国械注进20203170284
18.	GLUMA Bond Universal	Kulzer GmbH	国械注进20203170285
19.	In. Pact Admiral Paclitaxel-coated PTA Balloon Catheter	Medtronic, Inc.	国械注进20203030288
20.	ASAHI SASUKE Double Lumen Catheter (RX/OTW)	朝日インテック株式会社	国械注进20203030289
21.	Neuroform Atlas Stent System	Stryker Neurovascular	国械注进20203130290
Imported Class II Medical Devices
22.	Anti-dsDNA Reagent	INOVA Diagnostics, Inc.	国械注进20202400238
23.	AT	Roche Diagnostics GmbH	国械注进20202400239
24.	Lyphochek Specialty Immunoassay Control	Bio-Rad Laboratories, Inc.	国械注进20202400240
25.	Afinion Lipid Panel Control	Alere Technologies AS	国械注进20202400241
26.	CC 25mM	Roche Diagnostics GmbH	国械注进20202400242
27.	CONTOUR®NEXT controls	Ascensia Diabetes Care Holdings AG	国械注进20202400243
28.	Blank Cal	Roche Diagnostics GmbH	国械注进20202400244
29.	Diagnostic Ultrasound System	ESAOTE.S.p.A	国械注进20202060249
30.	KODEX – EPD System External Patches	EPD Research Ltd.	国械注进20202070250
31.	Surgical Microscope	Leica Microsystems （Schweiz） AG	国械注进20202060251
32.	Cardiopulmonary Exercise Testing System	SCHILLER AG	国械注进20202070252
33.	Coagulation Instrument	Forrenstrasse 2,6343 Rotkreuz, Switzerland	国械注进20202220253
34.	X-ray Tube Assemblies of Rotating Anode	Rontgenstrabe 24 ,22335 Hamburg, Germany	国械注进20202060254
35.	Electric Unit	大阪府大阪市中央区东心斋桥2-1-1	国械注进20202150255
36.	X-ray Tube Assemblies of Rotating Anode	Rontgenstrabe 24 ,22335 Hamburg, Germany	国械注进20202060256
37.	Electric Operating Table	/	国械注进20202150257
38.	PT Rec	Roche Diagnostics GmbH	国械注进20202400273
39.	TT	Roche Diagnostics GmbH	国械注进20202400274
40.	CoaguChek PT Test	Roche Diagnostics GmbH	国械注进20202400275
41.	BacT/ALERT PF Plus	bioMerieux, Inc.	国械注进20202400276
42.	AFIAS PCT Plus	Boditech Med Inc.	国械注进20202400277
43.	VITROS Immunodiagnostic Products NT-proBNPⅡ Controls	Ortho-Clinical Diagnostics	国械注进20202400278
44.	Fluorimetric immunoassay analyser（FIA）	Boditech Med Inc.	国械注进20202220279
45.	Clinical Chemistry Analyzer	Thermo Fisher Scientific Oy	国械注进20202220280
46.	CoaguChek XS Pro	Roche Diagnostics GmbH	国械注进20202220281
47.	Electric Motor for Dental Handpiece	麦科乐医疗器械有限公司	国械注进20202170282
48.	Digital Blood Pressure Monitor	InBody Co., Ltd.	国械注进20202070283
49.	Tabletop Refraction System	株式会社ニデック	国械注进20202160286
50.	Treadmill	Lode B.V.	国械注进20202070287
51.	Xpert® Nasopharyngeal Sample Collection Kit	Cepheid	国械注进20202220270
52.	Non-active Instruments for Mediastinoscope	KARL STORZ SE & Co. KG	国械注进20202020271
53.	DENTSPLY SIRONA Universal Stain and Overglaze	DENTSPLY International, Inc. DENTSPLY Ceramco	国械注进20202170272
Hong Kong, Macao or Taiwan Medical Device
54.	Electric Operating Table	Acomed	国械注许20202150009
55.	Vibrating Mesh Nebulizer	HCMED INNOVATIONS CO., LTD.	国械注许20202080008
56.	Eye Secret Multi-purpose Solution	Everestpharm	国械注许20203160010