NMPA Approved 120 Medical Devices in Jan, 2020

2020-02-29

In January, 2020, NMPA has approved a total of 120 medical devices. 72 of them are domestic Class III medical devices, 27 of them are imported Class III medical devices, 20 of them are imported Class II medical devices and one of them is Taiwan medical device.

Link: http://www.nmpa.gov.cn/WS04/CL21

Please find the approved imported medical devices in Jan., 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@chinameddevice.cn.

Approved Imported Medical Devices in January 2020

No.

Product Name

Registrant Name

Certificate Number

Imported Class III Medical Devices
1.	Spinal Dynamic Neutralization Fixation System	Zimmer GmbH	国械注进20203130001
2.	Trevo XP ProVue Retriever	Stryker Neurovascular	国械注进20203030002
3.	Xpert CT/NG Assay	Cepheid AB	国械注进20203400008
4.	cobas NHP Negative Control Kit for use on the cobas 6800/8800 Systems	Roche Diagnostics GmbH	国械注进20203400009
5.	NeuWave Certus Ablation Probes	NeuWave Medical，Inc.	国械注进20203010010
6.	NeuWave Certus Microwave Ablation System	NeuWave Medical，Inc.	国械注进20203010011
7.	Dedicated Breast PET System	Shimadzu Corporation	国械注进20203060012
8.	Thunder Guidewires	Medtronic Inc.	国械注进20203030013
9.	Intravascular Heat Exchange Catheter Kit	ZOLL Circulation，Inc.	国械注进20203030014
10.	Advanix Pancreatic Stent and NaviFlex Pushers	Boston Scientific Corporation	国械注进20203130015
11.	Hemodialysis Catheterization	Arrow International，Inc.	国械注进20203100016
12.	MAMBA and MAMBA Flex Microcatheter	Boston Scientific Corporation	国械注进20203030017
13.	Guideliner V3 Catheter	Vascular Solutions LLC	国械注进20203030018
14.	Lithotripsy Laser	W.O.M. World of Medicine GmbH	国械注进20203010019
15.	Single-use bipolar high-frequency ultrasound dual-output surgical instrument	OLYMPUS MEDICAL SYSTEM CORP.	国械注进20203010020
16.	Niti-S Esophageal Covered Stent	Taewoong Medical Co.，Ltd	国械注进20203130032
17.	Disposable Biopsy Needle	Möller Medical GmbH	国械注进20203140033
18.	GraftMax Button	ConMed Corporation	国械注进20203130034
19.	Tubing Systems for Continuous Blood Purification	Fresenius Medical Care AG & Co. KGaA	国械注进20203100035
20.	Ankle Fusion Plating System	In2Bones SAS	国械注进20203130036
21.	Infusomat plus Line	B. Braun Melsungen AG	国械注进20203140037
22.	LifeSpan® ePTFE Vascular Graft	LeMaitre Vascular，Inc.	国械注进20203130044
23.	Modified Sodium Hyaluronate Gel for Injection	Q-Med AB	国械注进20203130045
24.	Powerline PTCA Catheter	Kaneka	国械注进20203030046
25.	SwiftNINJA Steerable Microcatheter	Merit Medical Systems，Inc.	国械注进20203030047
26.	InQwire Amplatz Guide Wire	Merit Medical Systems，Inc.	国械注进20203030048
27.	FluidiTube 2.7F Infusion Micro Catheter	Callisyn Biomedical,Inc.	国械注进20203030049
Imported Class II Medical Devices
28	QUANTA Flash dsDNA Controls	INOVA Diagnostics，Inc.	国械注进20202400003
29	Infinity LC Clinical Edition / Triple Quad MS	Agilent Technologies Singapore (International) Pte. Ltd.	国械注进20202220004
30	FUJI DRI-CHEM NX700i	FUJIFILM Corporation	国械注进20202220005
31	Automated Liquid Nitrogen Stroage System	ThermoGenesis Corp.	国械注进20202220006
32	X-Ray Imaging System	KONICA MINOLTA	国械注进20202060007
33	Novaloc Matrix System	Valoc AG	国械注进20202170021
34	Dental Drills for Implant Surgery	OSSTEM IMPLANT Co.，Ltd.	国械注进20202170022
35	LMA Supreme	Teleflex Medical	国械注进20202080023
36	CELTRA Ceram porcelains	DENTSPLY International，Inc. Dentsply Ceramco	国械注进20202170024
37	Access hsTnI	Immunotech SAS，A Beckman Coulter Company	国械注进20202400025
38	D-DI2	Roche Diagnostics GmbH	国械注进20202400026
39	AT	Roche Diagnostics GmbH	国械注进20202400027
40	Automated Blood Coagulation Analyzer	SYSMEX CORPORATION	国械注进20202220028
41	Automated Blood Coagulation Analyzer	SYSMEX CORPORATION	国械注进20202220029
42	MRI Patient Monitoring System	MIPM Mammendorfer Institut für Physik und Medizin GmbH	国械注进20202070030
43	Cardiac Atrial Fibrillation analyzer	Applied Biomedical Systems BV	国械注进20202070031
44	Single Use Aspiration Needle	Olympus Medical Systems	国械注进20202020038
45	Spirometer	eResearchTechnology GmbH	国械注进20202070039
46	Powered Traction Equipment	Hill Laboratories	国械注进20202090040
47	Bone Conducted Hearing Aids	MED-EL Elektromedizinische Geräte GmbH	国械注进20202190041
Hong Kong, Macao or Taiwan Medical Device
48	“ICARES” IOL Delivery System (Sterile)	ICARES Medicus, Inc.	国械注许20202160001