In February 2018, the General Directorate approved the registration of 96 medical device product catalogs

From March 23 to February 2018, the State Food and Drug Administration approved a total of 96 medical device products. Among them, there are 58 medical device products of the third category in China, and 20 imported medical device products of the third category. The second category of medical device products 18 (specific products see annex).

Special announcement.

No.	product name	Registrant name	Registration number
The third type of medical device in the territory
1	Helicobacter pylori antibody reagents (immunohistochemistry)	Fuzhou Maixin Biotechnology Development Co., Ltd.	China National Medicine and Injection Corporation Limited 20183400035
2	X-ray computed tomography equipment	Suzhou Wave Shadow Medical Technology Co., Ltd.	China National Medicine Agency, Inc. 20183300036
3	Body Electric Lithotripsy	Beijing Yi Dalong Economic & Trade Development Co., Ltd. Sanhe Medical Devices Branch	National Instruments injection
4	Disposable non-absorbable ligation clips	Jiangsu Xinzhiyuan Medical Technology Co., Ltd.	China National Medicine Administration Corporation, Inc.
5	Disposable endoscope needle	Nanjing Miniature Medical Technology Co., Ltd.	China National Medicine Administration, Inc. 20183150039
6	Disposable high pressure contrast syringe and accessories	Mai Dewang (Suzhou) Medical Equipment Co., Ltd.	China National Medicine Administration Corporation, Inc. 20183660040
7	Disposable pump infusion set	Shandong Xinhua Ande Medical Products Co., Ltd.	China National Medicine Administration Corporation, Inc. 20183660041
8	Spinal interbody fusion cage	Zhejiang Guangci Medical Devices Co., Ltd.	China National Medicine Administration Bureau, Inc. 20183460042
9	Disposable burette infusion set with needle	Meiyi Medical Devices (Kunshan) Co., Ltd.	China National Medicine Administration Corporation, Inc. 20183660043
10	Non-compliant PTCA balloon dilation catheter	Beijing Dimax Medical Technology Co., Ltd.	National Machinery and Technology Inc.
11	Post-expanding PTCA balloon catheter	Hunan Epute Medical Devices Co., Ltd.	National Machinery and Technology Inc.
12	Metal bone needle	Changzhou Jianli Bond Medical Devices Co., Ltd.	National Medical Agency
13	PTA balloon catheter	Zhejiang Genchuang Medical Instrument Co., Ltd.	National Machinery and Technology Inc.
14	Non-absorbable band anchor	Beijing Zhong An Taihua Technology Co., Ltd.	China National Medicine Administration Corporation, Inc.
15	Hollow bone screws	Beijing Tianzhihang Medical Technology Co., Ltd.	National Medical Agency
16	Disposable pump infusion set	Shandong Xinhua Ande Medical Products Co., Ltd.	China National Medicine Agency, Inc. 20183660050
17	Disposable precision filtration infusion set	Deqing Xindeyi Medical Instrument Co., Ltd.	China National Medicine Administration Corporation, Inc. 20183660051
18	Intraocular lens	Aibonod (Beijing) Medical Technology Co., Ltd.	National Machinery and Technology Centered on 201,832,20052
19	One-time use Y connector kit	Shenzhen Shengli Medical Equipment Development Co., Ltd.	China National Medicine Corporation
20	PTCA balloon dilation catheter	Beijing Dimax Medical Technology Co., Ltd.	The national armed forces immunized 20183770054
21	Vaseline gauze	Zhijiang Aomei Medical Products Co., Ltd.	The national armed forces are punctured 20183640055
22	Ureaplasma urealyticum nucleic acid detection kit (fluorescent PCR method)	Jiangsu Shuo Shi Biotechnology Co., Ltd.	China National Medicine Agency, Inc. 20183400056
23	Gonococcus Nucleic Acid Detection Kit (Fluorescent PCR)	Jiangsu Shuo Shi Biotechnology Co., Ltd.	China National Medicine Agency, Inc. 20183400057
24	Chlamydia trachomatis nucleic acid detection kit (fluorescence PCR method)	Jiangsu Shuo Shi Biotechnology Co., Ltd.	China National Medicine Agency, Inc. 20183400058
25	Human papillomavirus nucleic acid detection kit (fluorescent PCR method)	Jiangsu Shuo Shi Biotechnology Co., Ltd.	China National Medicine Administration, Inc. 20183400059
26	Helicobacter pylori antigen detection kit (colloidal gold method)	Jiangsu Huayu Tailai Biotechnology Co., Ltd.	China National Medicine Administration Corporation Limited 20183400060
27	Neisseria gonorrhoeae/Chlamydia trachomatis/Ureaplasma urealyticum nucleic acid detection kit (Fluorescent PCR method)	Jiangsu Shuo Shi Biotechnology Co., Ltd.	China National Medicine Agency, Inc. 20183400061
28	Rubella virus IgG antibody detection reagent (Fluorescence immunochromatography)	Guangzhou Wanfu Biotechnology Co., Ltd.	China National Medicine Agency, Inc. 20183400062
29	Measles Virus IgG Antibody Detection Reagent (Fluorescence Immunochromatography)	Guangzhou Wanfu Biotechnology Co., Ltd.	China National Medicine Administration, Inc. 20183400063
30	Magnetic resonance imaging system	GE Healthcare (Tianjin) Co., Ltd.	China National Academy of Industry and Technology, 20182280064
31	X-ray computed tomography equipment	Shenyang Neusoft Medical Systems Co., Ltd.	Chinese medicine and injections 20183300065
32	Electronic tracheal endoscope	Zhuhai Meidehao Medical Technology Co., Ltd.	National Machinery and Technology Centered on 20183220066
33	Magnetic resonance imaging system	Kangda Intercontinental Medical Devices Co., Ltd.	China National Medicine Administration Corporation, Inc. 20183280067
34	Electronic straight endoscope	Guangzhou Ruida Medical Devices Co., Ltd.	National Machinery and Technology Department, Inc. 20183220068
35	Electronic lower digestive endoscope	Tuzhi (Shanghai) Medical Devices Co., Ltd.	National Machinery and Technology
36	Electronic gastrointestinal endoscopy	Tuzhi (Shanghai) Medical Devices Co., Ltd.	National Machinery and Technology
37	Magnetic resonance imaging system	GE Healthcare (Tianjin) Co., Ltd.	China National Medicine Administration, Inc., 20183280071
38	Disposable laparoscopic high-frequency surgical instruments	Hangzhou Guangdian Medical Instrument Co., Ltd.	National Machinery and Technology Department, Inc. 20183220072
39	Surgical navigation system	Shanghai Ailifeng Medical Technology Co., Ltd.	China National Academy of Industry and Technology, Inc. 20183540073
40	X-ray computed tomography equipment	Mingfeng Medical Systems Co., Ltd.	Chinese medicine, injection, 20183300074
41	Hepatitis B virus surface antigen assay kit (Chemiluminescence microparticle immunoassay)	Jiangsu Fulong Biotechnology Co., Ltd.	China National Medicine Administration, Inc. 20183401004
42	Hepatitis B Virus e Antibody Assay Kit (Chemiluminescence Microparticle Immunoassay)	Jiangsu Fulong Biotechnology Co., Ltd.	China National Medicine Administration, Inc. 20183401005
43	Hepatitis B virus e antigen assay kit (Chemiluminescence microparticle immunoassay)	Jiangsu Fulong Biotechnology Co., Ltd.	China National Medicine Agency, Inc. 20183401006
44	Hepatitis B virus pre-S1 antigen assay kit (Chemiluminescence microparticle immunoassay)	Jiangsu Fulong Biotechnology Co., Ltd.	China National Medicine Administration, Inc. 20183401007
45	Hepatitis B Virus Core Antibody Assay Kit (Chemiluminescence Microparticle Immunoassay)	Jiangsu Fulong Biotechnology Co., Ltd.	China National Medicine Administration, Inc. 20183401008
46	Hepatitis B Virus Surface Antibody Assay Kit (Chemiluminescence Microparticle Immunoassay)	Jiangsu Fulong Biotechnology Co., Ltd.	China National Medicine Administration, Inc. 20183401009
47	Hepatitis C Virus Antibody Assay Kit (Chemiluminescence Microparticle Immunoassay)	Jiangsu Fulong Biotechnology Co., Ltd.	National Arbitration Agency
48	Treponema pallidum Antibody Assay Kit (Chemiluminescence Microparticle Immunoassay)	Jiangsu Fulong Biotechnology Co., Ltd.	China National Medicine Administration Corporation, Inc. 20183401011
49	Disposable sterile syringe with needle	Huaian Hengchun Medical Equipment Co., Ltd.	National Machinery and Technology, Inc. 20183151012
50	Electronic gastrointestinal endoscopy	Shanghai Jiawang Endoscope Technology Co., Ltd.	Chinese medicine
51	Individualized mandibular reconstruction prosthesis	Xi'an Kegu Intelligent Machine Co., Ltd.	China National Academy of Industry and Technology, Inc. 20183461014
52	Tumor knee prosthesis	Beijing Aikang Yicheng Medical Equipment Co., Ltd.	National Machinery and Technology
53	U staple	Shanghai Kangding Medical Instrument Co., Ltd.	National Machinery and Technology Centered on 20183461016
54	Metal hollow screws	Shanghai Kangding Medical Instrument Co., Ltd.	National Machinery and Technology
55	Soft hydrophilic contact lens	Jiangsu Hailun Contact Lens Co., Ltd.	National Machinery and Technology Centered on 20183221018
56	Alginate dressing	Zhejiang Medical Ding Medical Dressing Co., Ltd.	China National Medicine Administration Corporation, Inc.
57	Human Immunodeficiency Virus Type 1 (HIV-1) DNA Detection Kit (Fluorescent PCR)	Tianjin Jingnaite Gene Biological Technology Co., Ltd.	National Machinery and Injecting 20183401020
58	Ultrasonic scalpel system	Changzhou Ruijie Biotechnology Co., Ltd.	National Machinery and Technology
Imported third medical devices
59	Color ultrasonic diagnostic system	Ultrasonix Medical Corporation	National machinery and injection into 20183230046
60	Potential therapy device	Medical Devices Co., Ltd.	National Machinery and Injection into 20183260047
61	Ho (Ho:YAG) Laser Treatment Machine	Lumenis Limited	National machinery and injection into 20183240048
62	Anti-p53 (DO7) Antibody Reagent (immunohistochemistry)	Ventana Medical Systems, Inc.	National Machinery and Injection into 20183400052
63	Nitric oxide flow controller	SLE Limited	National Machinery and Injection into 20183260066
64	Disposable intraocular laser fiber	Peregrine Surgical Ltd.	National machinery and injection into 20183240067
65	Anesthesia system	Datex-Ohmeda, Inc.	National Machinery and Injection into 20183540068
66	Medical angiography X-ray system	Philips Medical Systems Nederland B.V.	National Machinery and Machinery entered 20183300069
67	Baby incubator	Ohmeda Medical	National Machinery and Injection into 20183540070
68	X-ray computed tomography equipment	Siemens Healthcare GmbH	National Machinery and Injection into 20183300071
69	Respiratory gating system	Varian Medical Systems, Inc.	National Machinery and Injection into 20183320072
70	Portable color ultrasonic diagnostic system	FUJIFILM SonoSite, Inc.	National machinery and injection into 20183230073
71	Ho:YAG laser treatment machine	Cook Incorporated	National Machinery and Machinery entered 20183240074
72	Medical angiography X-ray system	Philips Medical Systems Nederland B.V.	National Machinery and Injection into 20183300075
73	X-ray computed tomography equipment	Toshiba Corporation	National Machinery and Injection into 20183300076
74	Optical interference tomography imaging system	Lightlab Imaging Inc.	National Machinery and Injection into 20183220077
75	Fully automatic nucleic acid purification and fluorescent PCR analyzer	Co., Ltd.	National machinery and injection into 20183400078
76	Continuous blood purification and plasma filtration adsorption equipment	MEDICA S.p.A.	National Machinery entered 20183450079
77	Abutments and accessories	SHINHUNG MST CO,. LTD	National Machinery and Injection into 20183631007
78	Dental implant	Biomet 3i	National Machinery and Injection into 20183631008
Imported Type II Medical Devices
79	Blood glucose meter	Roche Diabetes Care GmbH	National Machinery and Injection into 20182400044
80	Ultrasound diagnosis system	ALPINION MEDICAL SYSTEMS CO., LTD.	National machinery and injection into 20182230045
81	Hypophysis thermo-pulsation therapeutic apparatus	TearScience, Inc.	National Machinery and Injection into 20182260049
82	Quick vacuum mixing bowl	Summit Medical Limited	National Machinery injection into 20182100050
83	Stoma Protective Skin Spray	Coloplast A/S	National machinery and injection into 20182660051
84	Shoulder surgery tools	ConMed Corporation	National Machinery and Injection into 20182220053
85	Dental planter	OSSTEM IMPLANT Co., Ltd.	National Machinery and Injection into 20182550054
86	Endoscopic camera	W.O.M. WORLD OF MEDICINE GmbH	National Machinery and Technology injected into 20182220055
87	Ultrasound treatment instrument	Ito Ultra Shortwave Co., Ltd.	National machinery and injection into 20182230056
88	Surgical microscope	ATMOS Medizin Technik GmbH & Co. KG	National Machinery and Injection into 20182220057
89	Ovulation tester	Fairhaven Health	National Machinery and Injection into 20182400058
90	headlamp	HEINE Optotechnik GmbH&Co. KG	National Machinery and Injection into 20182200059
91	Dental treatment unit	Belmont Manufacturing Co., Ltd	National Machinery and Injection into 20182550060
92	Corneal endothelium microscope	トーメーコーポレート	National Machinery and Injection into 20182220061
93	Disposable hypodermic needle electrode	Natus Neurology Incorporated	National Machinery and Injection into 20182210062
94	Infusion blood transfusion warmer	Barkey GmbH & Co. KG.	National Machinery and Injection into 20182405063
95	Electric bone tissue surgery tools	Stryker Instruments	National Machinery and Injection into 20182100064
96	Blood glucose analyzer	SD Biosensor, Inc.	National Machinery entered 20182400065

food drug General Administration of Supervision

March 16, 2018