NMPA Approved 170 Medical Devices in Feb., 2020

2020-04-16

In February, 2020, NMPA has approved a total of 170 medical devices. 118 of them are domestic Class III medical devices, 16 of them are imported Class III medical devices, 32 of them are imported Class II medical devices and 4 of them are Hongkong, Macao or Taiwan medical device.

Link: http://www.nmpa.gov.cn/directory/web/WS04/images/ufq80tKpxre84La9udzA7b7WMjAyMMTqtdo0MrrFuau45ri9vP4uZG9j.doc

Please find the approved imported medical devices in Feb., 2020 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 info@inspirativemed.com.

Approved Imported Medical Devices in February 2020

No.

Product Name

Registrant Name

Certificate Number

Imported Class III Medical Devices
1.	CXI Support Catheter	Zimmer GmbH	国械注进20203030061
2.	Powerline PTCA Catheter	Stryker Neurovascular	国械注进20203030062
3.	Continuous blood purification equipment	Cepheid AB	国械注进20203100063
4.	Single Chamber Temporary External Pacemaker	Roche Diagnostics GmbH	国械注进20203120064
5.	MiniPolar Percutaneous Electrosurgical Probes	NeuWave Medical，Inc.	国械注进20203010065
6.	Implantable Cardioverter/Defibrillator Leads	NeuWave Medical，Inc.	国械注进20203120066
7.	Implantable Cardioverter/Defibrillator Leads	Shimadzu Corporation	国械注进20203120067
8.	COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, version 2.0	Merit Medical Systems, Inc	国械注进20203400083
9.	RSV FIA	株式会社カネカ	国械注进20203400084
10.	Hernia Mesh	Fresenius Medical Care AG & Co. KGaA	国械注进20203130090
11.	Hernia Mesh	Medtronic Inc.	国械注进20203130091
12.	Balloon Guide Catheters	Teleflex Medical	国械注进20203030092
13.	Teeth WhiteningGel	Cardiac Pacemakers Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation	国械注进20203630093
14.	Self-Adhesive Cement	Cardiac Pacemakers Incorporated, a wholly owned subsidiary of Guidant Corporation, a wholly owned subsidiary of Boston Scientific Corporation	国械注进20203170094
15.	PTA Dilatation Catheter	Roche Diagnostics GmbH	国械注进20203030097
16.	Modified Sodium Hyaluronate Gel for Injection	Quidel Corporation	国械注进20203130098
Imported Class II Medical Devices
17	Hematology Analyzer	HORIBA ABX SAS	国械注进20202220050
18	Philips IntelliSite Pathology Solution	Philips Electronics Nederland B.V.	国械注进20202220051
19	Ultrasonics dental descaler equipment	株式会社ナカニシ	国械注进20202170052
20	ImmunoCAP Total IgE Control LMH	Phadia AB	国械注进20202400053
21	Access 25(OH) Vitamin D Total Calibrators	Beckman Coulter, Inc.	国械注进20202400054
22	Access 25(OH) Vitamin D Total Calibrators	Beckman Coulter, Inc.	国械注进20202400055
23	Sealants	Dental Life Sciences （Mfg） Ltd	国械注进20202170056
24	BIOPSY PUNCH	Kai Industries Co., Ltd.	国械注进20202020057
25	MiniGrip Percutaneous Surgical Handles	Teleflex Medical	国械注进20202020058
26	Accessories for Implant	Zimmer Dental, Inc.	国械注进20202170059
27	Surgical Blade	（주）아이리	国械注进20202020060
28	Steam sterilizers	MELAG Medizintechnik oHG	国械注进20202110068
29	Dental Unit	株式会社モリタ東京製作所	国械注进20202170069
30	Retinal Camera	IMAGINE EYES SA	国械注进20202160070
31	Treadmill Ergometer	h/p/cosmos sports & medical gmbh	国械注进20202070071
32	Euroklav series	MELAG Medizintechnik oHG	国械注进20202110072
33	X-Ray Imaging System	AGFA NV	国械注进20202060073
34	Con P+	Roche Diagnostics GmbH	国械注进20202400074
35	Con P+	Roche Diagnostics GmbH	国械注进20202400075
36	ARCHITECT B·R·A·H·M·S PCT Reagent Kit	Abbott GmbH & Co. KG	国械注进20202400076
37	Der Fib Con	Roche Diagnostics GmbH	国械注进20202400077
38	Con P+	Roche Diagnostics GmbH	国械注进20202400078
39	MRX LIATEST FDP	Medirox AB	国械注进20202400079
40	ARCHITECT B·R·A·H·M·S PCT Calibrators	Abbott GmbH & Co. KG	国械注进20202400080
41	ARCHITECT B·R·A·H·M·S PCT Calibrators	Abbott GmbH & Co. KG	国械注进20202400081
42	Con P+	Roche Diagnostics GmbH	国械注进20202400082
43	Closed System Transfer Device (CSTD)	אקווהשילד מדיקל בע	国械注进20202140085
44	Filaprop™ Sterile Non-Absorbable Surgical Suture U.S.P	Meril Endo Surgery Pvt Ltd	国械注进20202020086
45	Filaprop™ Sterile Non-Absorbable Surgical Suture U.S.P	Meril Endo Surgery Pvt Ltd	国械注进20202020087
46	Radiolucent Drill	Gebr. Brasseler GmbH & Co. KG	国械注进20202040088
47	MICS Saw blade	MAKO SURGICAL CORP.	国械注进20202040089
48	Proxis™ Ureteral Access Sheath	C. R. Bard, Inc.	国械注进20202020095
Hong Kong, Macao or Taiwan Medical Device
49	Non-Mydriatic Auto Fundus Camera	Crystalvue Medical Corporation	国械注许20202160002
50	Pureye Monthly Disposable Contact Lens	Yongsheng optics co., LTD	国械注许20203160003
51	Pureye Monthly Disposable Contact Lens	Yongsheng optics co., LTD	国械注许20203160004
52	Angel Flush Syringe	Nanguang Chemical Pharmaceutical Co., Ltd.	国械注许20203140005