NMPA Approved 172 Medical Devices in March, 2020

2020-04-17

In March, 2020, NMPA has approved a total of 172 medical devices. 131 of them are domestic Class III medical devices, 18 of them are imported Class III medical devices, 22 of them are imported Class II medical devices and 1 of them is from the Taiwan medical device.

Link: http://www.nmpa.gov.cn/WS04/CL2121/376511.html

Please find the approved imported medical devices in March, 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 March 2020

No.

Product Name

Registrant Name

Certificate Number

Imported Class III Medical Devices
1.	Video Nasopharyngoscope	XION GmbH	国械注进20203060100
2.	NexCore Dual-cured core build-up composite Resin	META BIOMED CO., LTD.	国械注进20203170104
3.	MCS HyperSoft 3D	MicroVention, Inc.	国械注进20203130105
4.	Roxolid Implant	Institut Straumann AG	国械注进20203170106
5.	DIVERGENCE Anterior Cervical Fusion System	Medtronic Sofamor Danek USA, Inc.	国械注进20203130123
6.	ToggleLoc System	Biomet Sports Medicine	国械注进20203130124
7.	Slittable Outer Catheter	St. Jude Medical Cardiac Rhythm Management Division	国械注进20203030125
8.	Slittable Inner Catheter	St. Jude Medical Cardiac Rhythm Management Division	国械注进20203030126
9.	PreludeEase Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	国械注进20203030127
10.	Micro Catheter	株式会社パイオラックスメディカルデバイス	国械注进20203030128
11.	REDAPT Acetabular System	Smith & Nephew, Inc.	国械注进20203130129
12.	ATTUNE Stemmable Tibial Components	DePuy (Ireland)	国械注进20203130130
13.	XEN Glaucoma Treatment System	Allergan	国械注进20203160132
14.	Restoris MultiCompartmental Knee System	MAKO SURGICAL CORP.	国械注进20203130133
15.	Abutment and Component	MegaGen Implant Co.,Ltd.	国械注进20203170134
16.	Cleavage Medium	Vitrolife Sweden AB	国械注进20203180135
17.	R350 Guidewire	Vascular Solutions LLC	国械注进20203030136
18.	DIVERGENCE-L Anterior/Oblique Lumbar Fusion System	Medtronic Sofamor Danek USA, Inc.	国械注进20203130137
Imported Class II Medical Devices
19	Knives for Ophthalmic Surgery for Single-use	SIDAPHARM P.C.	国械注进20202160096
20	VitalStim® Plus Electrotherapy System	DJO, LLC	国械注进20202090099
21	Arthroscopy Instruments	Biomet Sports Medicine	国械注进20202040101
22	Dental Drills for Implant Surgery	OSSTEM IMPLANT Co., Ltd.	国械注进20202170102
23	GLUMA Ceramic Primer	Kulzer GmbH	国械注进20202170103
24	ImmunoCAP Allergen t6, Mountain Juniper	Phadia AB	国械注进20202400107
25	ImmunoCAP Allergen w22, Japanese Hop	Phadia AB	国械注进20202400108
26	QUANTA Flash β2GP1-Domain1 Controls	INOVA Diagnostics, Inc.	国械注进20202400109
27	ImmunoCAP Allergen g6, Timothy	Phadia AB	国械注进20202400110
28	ImmunoCAP Allergen g2, Bermuda grass	Phadia AB	国械注进20202400111
29	ImmunoCAP Allergen t11, Maple leaf sycamore, London plane	Phadia AB	国械注进20202400112
30	ArcCHECK	Sun Nuclear Corporation	国械注进20202050113
31	Dental Electrical Motor System	Kaltenbach & Voigt GmbH	国械注进20202170114
32	Mobilization and Treatment table	Lojer Oy	国械注进20202150115
33	Medical Images Processing Software	Siemens Healthcare GmbH	国械注进20202210116
34	MapCHECK3	Sun Nuclear Corporation	国械注进20202050117
35	Automatic Immunoblotting System	HUMAN Gesellschaft fur Biochemica und Diagnostica mbH	国械注进20202220118
36	Endo Irrigation Tip	VDW GmbH	国械注进20202170119
37	The Actreen Range	B. Braun Medical SAS	国械注进20202140120
38	NuSmile ZR Crowns	NuSmile.Ltd	国械注进20202170121
39	Rainbow Shine Block	Genoss Co., Ltd.	国械注进20202170122
40	Long Term Temporary Resin Cement	B.J.M.LABORATORIES LTD.	国械注进20202170131
Hong Kong, Macao or Taiwan Medical Device
41	Medical Support Stocking	SunPolar	国械注许20202160002