NMPA Approved 235 Medical Devices in April, 2020

2020-06-02

In April, 2020, NMPA has approved a total of 235 medical devices. 134 of them are domestic Class III medical devices, 38 of them are imported Class III medical devices, 62 of them are imported Class II medical devices and 1 of them is a Taiwan medical device.

Link: http://www.nmpa.gov.cn/WS04/CL2121/377719.html

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

No.

Product Name

Registrant Name

Certificate Number

Imported Class III Medical Devices
1.	OptiCross™ HD 60MHz Coronary Imaging Catheter	Boston Scientific Corporation	国械注进20203060148
2.	ULTRASONIC A/B SCANNERAND PACHYMETER	株式会社トーメーコーポレーション	国械注进20203160149
3.	CT Images Analysis and Processing Software	Siemens Healthcare GmbH	国械注进20203210150
4.	Zilver PTX Drug Eluting Peripheral Stent	Cook Ireland Limited	国械注进20203130151
5.	Gutta Percha Points	META BIOMED CO., LTD	国械注进20203170159
6.	Guidewire	株式会社パイオラックスメディカルデバイス	国械注进20203030160
7.	Lifestream Balloon Expandable Vascular Covered Stent	Clearstream Technologies Ltd.	国械注进20203130161
8.	Merit Maestro Microcatheter	Merit Medical Systems, Inc.	国械注进20203030162
9.	DIVERGENCE Anterior Cervical Fusion System	Medtronic Sofamor Danek USA, Inc.	国械注进20203130163
10.	Wolverine Coronary Cutting Balloon MONORAIL Microsurgical Dilatation Device	Boston Scientific Corporation	国械注进20203030164
11.	Juvéderm VOLIFT with Lidocaine	Allergan	国械注进20203130165
12.	EmboTrap Revascularization System	Neuravi Limited	国械注进20203030166
13.	Paclitaxel elution of high-pressure shunt balloon Dilatation Catheter	CARDIONOVUM GmbH	国械注进20203030167
14.	IntellaNav ST Ablation Catheter	Boston Scientific Corporation	国械注进20203010195
15.	Ultrasound System	BK Medical ApS	国械注进20203060196
16.	Green Laser Photocoagulator	株式会社ニデック	国械注进20203160197
17.	Yellow Laser Photocoagulator	株式会社ニデック	国械注进20203160198
18.	SoundStar Eco 8F Ultrasound Catheter	Biosense Webster, Inc.	国械注进20203060199
19.	Diagnostic Ultrasound System and Transducers	Philips Ultrasound, Inc.	国械注进20203060200
20.	Magnetic Resonance Equipment	Philips Medical Systems Nederland B.V.	国械注进20203060201
21.	HelixAR Electosurgical Unit with Argon Beam Coagulator	CONMED CORPORATION	国械注进20203010202
22.	Glass Ionomer Dental Cements	LASCOD S.P.A.	国械注进20203170203
23.	LuxaCrown	DMG Chemisch-Pharmazeutische Fabrik GmbH	国械注进20203170204
24.	Haemofiltration line	HAEMOTRONIC S.p.A.	国械注进20203100205
25.	REDAPT Stem	Smith & Nephew, Inc.	国械注进20203130206
26.	Aequalis Ascend Flex Shoulder System	TORNIER S.A.S.	国械注进20203130207
27.	Teeth Whitening Gel	American Hi Teeth Science and Technology Inc.	国械注进20203170208
28.	PreludeEase Hydrophilic Sheath Introducer	Merit Medical Systems, Inc.	国械注进20203030218
29.	Percutaneous Introducer Sheath	optimed Medizinische Instrumente GmbH	国械注进20203030219
30.	Soft Contact Lens	VOCOL Co.,Ltd.	国械注进20203160220
31.	Xpert Carba-R Assay	Cepheid	国械注进20203400221
32.	Aptima HCV Quant Dx Assay	Hologic, Inc.	国械注进20203400222
33.	Cellbind Direct Type	Sanquin Reagents B.V.	国械注进20203400223
34.	Panoramic X-ray systems	CEFLA S.C	国械注进20203060224
35.	InMode System	Invasix Ltd.	国械注进20203010225
36.	デジタル式汎用X線透視診断装置(Digital X-ray Radiography Fluoroscopy system)	株式会社　島津製作所	国械注进20203060226
37.	Virage OCT Spinal Fixation System	Zimmer Biomet Spine, Inc.	国械注进20203130236
38.	LIGHT-CURING COMPOSITE RESIN FOR CROWN AND BRIDGE	株式会社松風	国械注进20203170237
Imported Class II Medical Devices
39.	AFIAS Tn-I Plus	Boditech Med Inc.	国械注进20202400138
40.	VITROS Chemistry Products LDHI Slides	Ortho-Clinical Diagnostics, Inc.	国械注进20202400139
41.	VIDAS® High sensitive Troponin I (TNHS)	BIOMERIEUX S.A.	国械注进20202400140
42.	Air Scaler	W&H Dentalwerk Bürmoos GmbH	国械注进20202170141
43.	PET drug injection system	株式会社ユニバ一サル技研 (Universal Giken Co. Ltd.)	国械注进20202060142
44.	Vestibular Autorotation Test	Western Systems Research, Inc.	国械注进20202070143
45.	Phototherapy System	NEOMEDLIGHT	国械注进20202090144
46.	Electroencephalograph	EB NEURO SPA	国械注进20202070145
47.	DP 200	FFEI Ltd.	国械注进20202220146
48.	CO2 Incubator	ASTEC CO.,LTD.	国械注进20202220147
49.	AtriaPak Knitted Gingival Non-Medicated Retraction Cord	아트리아	国械注进20202170152
50.	Dental implant drill	MIS Implants Technologies Ltd.	国械注进20202170153
51.	Dental Zirconia Ceramic Blocks	Amann Girrbach AG	国械注进20202170154
52.	Dental Zirconia Ceramic Blocks	Amann Girrbach AG	国械注进20202170155
53.	Thopaz/Thopaz+ passive devices	Medela AG	国械注进20202140156
54.	QL 2530 Inflation Device	Atrion Medical Products, Inc.	国械注进20202030157
55.	DORO® Blades	pro med instruments GmbH	国械注进20202030158
56.	TiBrush	Institut Straumann AG	国械注进20202170168
57.	Porcelain Etchant	BISCO, INC.	国械注进20202170169
58.	Endoscopy instruments for orthopedics	T.A.G. MEDICAL PRODUCTS CORPORATION LTD.	国械注进20202040170
59.	CC 25mM	Roche Diagnostics GmbH	国械注进20202400171
60.	PT Screen	Roche Diagnostics GmbH	国械注进20202400172
61.	Con P	Roche Diagnostics GmbH	国械注进20202400173
62.	Kaolin	Roche Diagnostics GmbH	国械注进20202400174
63.	TT	Roche Diagnostics GmbH	国械注进20202400175
64.	TEG® Hemostasis System QC Level 2	Haemonetics S.A.	国械注进20202400176
65.	QUANTA Flash® dsDNA Reagents	INOVA Diagnostics, Inc.	国械注进20202400177
66.	Fibrinogen	Roche Diagnostics GmbH	国械注进20202400178
67.	STA – Cephascreen	Roche Diagnostics GmbH	国械注进20202400179
68.	Con N	Roche Diagnostics GmbH	国械注进20202400180
69.	Fibrinogen	Roche Diagnostics GmbH	国械注进20202400181
70.	TEG® Hemostasis System QC Level 1	Haemonetics S.A.	国械注进20202400182
71.	光トポグラフィ装置 (Quantitative imaging device for brain function)	株式会社日立製作所	国械注进20202070183
72.	CT Diagnostic Image Processing Software	キヤノンメディカルシステムズ株式会社	国械注进20202210184
73.	Vision Screener	Plusoptix GmbH	国械注进20202160185
74.	SynergyUHD4 Arthroscopy Camera System	Arthrex,Inc.	国械注进20202060186
75.	Ultrasonic image processing software	キヤノンメディカルシステムズ株式会社	国械注进20202210187
76.	Venus Versa	Venus Concept Ltd.	国械注进20202090188
77.	Auto Refractometer	株式会社レクザム	国械注进20202160189
78.	Medical Image Processsing Software	キヤノンメディカルシステムズ株式会社	国械注进20202210190
79.	Highspeed motordrill system	Adeor Medical AG	国械注进20202010191
80.	Surgical Microscope	Leica Microsystems （Schweiz） AG	国械注进20202160192
81.	Low Speed Handpieces	MK-dent GmbH	国械注进20202170193
82.	Automatic Endoscope Reprocessor	ADVANCED STERILIZATION PRODUCTS	国械注进20202110194
83.	Integra Micromanipulation System	Research Instruments Ltd	国械注进20202180209
84.	ErigoBasic	Hocoma AG	国械注进20202190210
85.	ImmunoCAP Specific IgE Negative Control	Phadia AB	国械注进20202400211
86.	ImmunoCAP Specific IgE Control L	Phadia AB	国械注进20202400212
87.	ImmunoCAP Specific IgE Control H	Phadia AB	国械注进20202400213
88.	QuikRead go iFOBT	Orion Diagnostica Oy	国械注进20202400214
89.	ImmunoCAP Specific IgE Control M	Phadia AB	国械注进20202400215
90.	Orthodontic Ceramic bracket	HT Co., Ltd	国械注进20202170216
91.	Core Decompression instruments Kit & X-REAM Expandable Reamer	Wright Medical Technology, Inc.	国械注进20202040217
92.	Hypertonic Sea Water Solution	YSLAB	国械注进20202140227
93.	Sterile physiologic sea water	YSLAB	国械注进20202140228
94.	MEDRAD sterile sheaths	KARL STORZ SE ＆ Co. KG	国械注进20202160229
95.	Humer 050 Decongestion – nasal spray	LABORATOIRE DE DIFFUSION DE PRODUITS DE SANTE APPLIQUEE	国械注进20202140230
96.	Unimer pediatric isotonic 9%, nasal spray	LABORATOIRE DE DIFFUSION DE PRODUITS DE SANTE APPLIQUEE	国械注进20202140231
97.	ISOMAR SPRAY BABY + CAMOMILLA	COSWELL S.P.A.	国械注进20202140232
98.	Dental drills	MOZO-GRAU, S.A.	国械注进20202170233
99.	Surgical drill	MegaGen Implant Co.,Ltd.	国械注进20202170234
100.	lncision protector	Jiangxi 3L Medical Products Group （Cambodia） Co., Ltd.	国械注进20202140235
Hong Kong, Macao or Taiwan Medical Device
101.	Eye secret soft contact lens	Everestpharm	国械注许20203160007