Just recently, CFDA announced 167 approved medical device inventories

January 23 hearing January 22, CFDA released last December by the Board approved the registration of medical device products listed on the market.
In December 2017, the council approved a total of registration medical instruments There are 167 products, of which 96 are category III medical devices, 22 are category III medical devices, and 49 are category II medical devices.
Overall, approved IVD, consumables is the most. Among them, Mindray, Ai Kang biological were 9 products were approved, is more approved products enterprise.
In the field of medical equipment, Lianxiang won the registration certificate for three medical devices of X-ray computed tomography equipment, magnetic resonance imaging system and X-ray computed tomography equipment this month.
Serial number
product name
Name of the registrant
Registration card number
The third category of medical equipment
1
Zika virus nucleic acid detection kit (fluorescence PCR method)
Shanghai Zhijiang Biotechnology Co., Ltd.
State equipment injection standard 20173401534
2
Drug-eluting balloon catheters
Liaoning Yin Yi Biotechnology Co., Ltd.
State equipment injection standard 20173771535
3
Disposable precision bag filter with infusion needle
Chengdu Xinjin thing Feng Medical Devices Co., Ltd.
Guoliang injection standard 20173661536
4
Disposable bag infusion
With needle
Chengdu Xinjin thing Feng Medical Devices Co., Ltd.
Guotai registration 20173661537
5
Disposable self-destruction sterile syringes with needles
Yunnan Sanxin Medical Technology Co., Ltd.
State equipment injection standard 20173151538
6
One-time use of venous blood collection needle
Zhuhai Kangli Lai Technology Co., Ltd.
State equipment injection standard 20173151539
7
Disposable intravenous catheter
Henan Camel Medical Devices Group Co., Ltd.
State equipment injection standard 20173151540
8
Use disposable evaporative infusion
With needle
Shenyang Beihua Medical Co., Ltd.
State equipment is directed at 20173661541
9
Disposable pressure extension tube
Tianjin Soma Technology Co., Ltd.
State equipment registration is 20173661542
10
Disposable hemodialysis tubing
Fujian Chang Gung Medical Biotechnology Co., Ltd.
State equipment injection standard 20173451543
11
Polyurethane foam dressings
Shanghai Asia Australia limited health care products
the company
State equipment registration of 20173641544
12
Disposable anesthetic puncture bag
Henan Camel Best Medical Devices Co., Ltd.
State equipment registration is 20173661545
13
Metal cable
Changzhou Jiushuo Medical Devices Co., Ltd.
State equipment registration of 20173461546
14
Disposable pressure connection tube
UniMedic Dick Instruments (Shenzhen) Co., Ltd.
State equipment injection standard 20173661547
15
One-time use of venous blood collection needle
Shandong Zhu Pharmaceutical Group Co., Ltd.
State equipment injection standard 20173151548
16
Hollow screw
Chuanghui medical equipment Jiangsu Co., Ltd.
The country is registered in 20173461549
17
Metal cable system
Jiangsu Hope Medical Devices Co., Ltd.
Guolujiao 20173461550
18
Hollow bone screw (non-locking)
Beijing Branch instrument Bonn Medical Devices Technology Co., Ltd.
State equipment registration of 20173461551
19
PEEK interbody fusion cage
Wuxi Wen Tai Baide Medical Devices Co., Ltd.
State equipment registration of 20173461552
20
Cable anchor
Shanghai Keli Tai Medical Technology Co., Ltd.
State equipment registration of 20173461553
21
Hollow bone screw (non-locking)
Weifang Reiki Medical Devices Co., Ltd.
State equipment registration of 20173461554
22
Hip prosthesis - ceramic femoral head
And pads
Beijing Montage Medical Devices Co., Ltd.
State equipment registration of the standard 20173461555
23
Hip prosthesis - acetabular system
Beijing Montage Medical Devices Co., Ltd.
State equipment registration of 20173461556
24
Metal cable internal fixation system
Beijing Fuller Technology Development Co., Ltd.
The country is registered in 20173461557
25
Laminating system
Zhejiang Jia You Medical Devices Co., Ltd.
State equipment registration of 20173461558
26
Rib plate
Suzhou Love Technology Development Co., Ltd.
State Administration of Industry Note 20173461559
27
High-frequency surgical equipment
Guangdong 100 Health Medical Devices Co., Ltd.
State equipment injection standard 20173251560
28
Cold saline irrigation RF ablation catheter
Shenzhen Hui Tai Medical Devices Co., Ltd.
Guoliang injection standard 20173771561
29
X-ray computed tomography equipment
United Film (Changzhou) Medical Technology Co., Ltd.
State equipment injection standard 20173301562
30
Bipolar RF surgical head
Fang Run Medical Device Technology (Shanghai) Co., Ltd.
State equipment registered in 20173251563
31
Oral and maxillofacial cone beam computer tomography equipment
Shanghai Youji Medical Imaging Equipment Co., Ltd.
State equipment injection standard 20173301564
32
Magnetic resonance imaging system
Shanghai Liangyu Medical Technology Co., Ltd.
State equipment registration of 20173281565
33
Infant cabin oxygen
Wuhan Hai Borui Technology Co., Ltd.
Guoliang injection standard 20173261566
34
Automatic chemiluminescence immunoassay analyzer
Yancheng Biomedical Biotechnology Co., Ltd.
State equipment injection standard 20173401567
35
Real-time fluorescence quantitative PCR instrument
Suzhou Baiyuan Gene Technology Co., Ltd.
Guoliang injection standard 20173401568
36
X-ray computed tomography equipment
Shanghai Liangyu Medical Technology Co., Ltd.
State equipment injection standard 20173301569
37
Implanted pacemakers
First Health Technology (Shenzhen) Co., Ltd.
State equipment registration of 20173211570
38
Ferritin Assay Kit (Chemiluminescence Immunoassay)
Aikang Biotechnology (Hangzhou) Co., Ltd.
Guoliang injection standard 20173401571
39
Total prostate specific antigen (tPSA) detection reagent
(Chemiluminescence immunoassay)
Aikang Biotechnology (Hangzhou) Co., Ltd.
State equipment registered at 20173401572
40
Squamous cell carcinoma antigen calibrator
Shenzhen Mindray Biomedical Electronics Co., Ltd.
Guoliang injection standard 20173401573
41
Gastrin-releasing peptide precursor control
Shenzhen Mindray Biomedical Electronics Co., Ltd.
Guoliang injection standard 20173401574
42
Human Epididymal Protein 4 Calibrator
Shenzhen Mindray Biomedical Electronics Co., Ltd.
State equipment injection standard 20173401575
43
Hepatitis B virus e antigen calibrator
Shenzhen Mindray Biomedical Electronics Co., Ltd.
Guoliang injection standard 20173401576
44
Hepatitis B virus core antibody IgM control
Shenzhen Mindray Biomedical Electronics Co., Ltd.
State equipment injection standard 20173401577
45
Cytokeratin 19 fragment (CYFRA21-1) detection kit (chemiluminescence immunoassay)
Aikang Biotechnology (Hangzhou) Co., Ltd.
State equipment injection standard 20173401578
46
A number of cancer marker substance control
Shenzhen Mindray Biomedical Electronics Co., Ltd.
State equipment registered in 20173401579
47
Cancer Antigen 125 (CA125)
Detection reagents (chemiluminescence immunoassay
Analysis)
Aikang Biotechnology (Hangzhou) Co., Ltd.
Guoliang injection standard 20173401580
48
Carbohydrate antigen 19-9 (CA19-9) detection reagent (chemiluminescence immunoassay)
Aikang Biotechnology (Hangzhou) Co., Ltd.
State equipment registered in 20173401581
49
AFP (AFP) detection reagent (chemiluminescence immunoassay)
Aikang Biotechnology (Hangzhou) Co., Ltd.
State equipment injection standard 20173401582
50
Carbohydrate antigen 242 calibrator
Shenzhen Mindray Biomedical Electronics Co., Ltd.
Guoliang injection standard 20173401583
51
50 carbohydrate antigen calibrator
Shenzhen Mindray Biomedical Electronics Co., Ltd.
Guoliang injection standard 20173401584
52
Gastrin-releasing peptide precursor calibrator
Shenzhen Mindray Biomedical Electronics Co., Ltd.
Guoliang injection standard 20173401585
53
Carcinoembryonic antigen (CEA) detection reagent (chemiluminescence immunoassay)
Aikang Biotechnology (Hangzhou) Co., Ltd.
Guoliang injection standard 20173401586
54
Hepatitis B virus core antibody IgM calibrator
Shenzhen Mindray Biomedical Electronics Co., Ltd.
Guoliang injection standard 20173401587
55
Disposable positive pressure connector
Jiangxi Feng Pro Medical Devices Co., Ltd.
State equipment injection standard 20173661588
56
Disposable anti-acupuncture needle
Jiangxi Feng Pro Medical Devices Co., Ltd.
State equipment injection standard 20173151589
57
Disposable flow setting fine-tuning infusion set with needle
Liaoning Zhongyuan Medical Devices Co., Ltd.
Guoliang injection standard 20173661590
58
Soft hydrophilic contact lens
Haichang Contact Lens Co., Ltd.
Guoliang injection standard 20173221591
59
Soft hydrophilic contact lens
Haichang Contact Lens Co., Ltd.
Guoliang injection standard 20173221592
60
Disposable precision filter infusion
Changzhou Medical Equipment Factory Co., Ltd.
State equipment is injected at 20173661593
61
Alginate dressings
Qingdao Mingyue Biomedical Materials Co., Ltd.
State equipment registered at 20173641594
62
Hollow fiber dialyzer
Weihai Wei high blood purification Products Co., Ltd.
State equipment injection standard 20173451595
63
Chlamydia pneumoniae IgM antibody test kit (colloidal gold method)
Lanzhou Yahua Biotechnology Co., Ltd.
Guoliang injection standard 20173401596
64
Chlamydia pneumoniae IgG antibody test kit (colloidal gold method)
Lanzhou Yahua Biotechnology Co., Ltd.
State equipment injection standard 20173401597
65
A / B influenza antigen detection kit (colloidal gold method)
Jiangsu Master Biotechnology Co., Ltd.
Guoliang injection standard 20173401598
66
Hepatitis B virus surface antigen, surface antibody, e antigen, e antibody, core antibody detection reagent
(Latex method)
Hangzhou Bo Extension Biological Technology Co., Ltd.
State equipment injection standard 20173401599
67
Human TERT gene promoter mutation detection kit
(PCR-fluorescence probe method)
Beijing Pan Son Gene Technology Co., Ltd.
State equipment injection standard 20173401600
68
Squamous cell carcinoma antigen (SCC) detection kit (chemiluminescence immunoassay)
Aikang Biotechnology (Hangzhou) Co., Ltd.
Guoliang injection standard 20173401601
69
Human IDH1 gene mutation detection kit (PCR-fluorescence probe method)
Beijing Pan Son Gene Technology Co., Ltd.
Guoliang injection standard 20173401602
70
Human Epididymal Protein 4 (HE4) Assay Kit (Enzyme-Linked Immunosorbent Assay)
Beijing Sheng Fat Biotechnology Co., Ltd.
Guoliang injection standard 20173401603
71
Free prostate-specific antigen (fPSA) detection reagent (chemiluminescence immunoassay)
Aikang Biotechnology (Hangzhou) Co., Ltd.
Guoliang injection standard 20173401604
72
Gene sequencer
Watson Wuhan Science and Technology Co., Ltd. made
Guoliang injection standard 20173401605
73
Zika virus nucleic acid detection kit (PCR-fluorescence probe method)
Zhongshan University Daan Gene Co., Ltd.
Guoliang injection standard 20173401606
74
Metal spicules
Suzhou Kang Li orthopedic equipment Co., Ltd.
State equipment registration of the standard 20173461607
75
Disposable infusion sets
Shandong Weigao Group Medical Polymer Co., Ltd.
Guoliang injection standard 20173151608
76
Hemodialysis concentrate
Jitai (Shanghai) Biotechnology Co., Ltd.
Guoliang injection standard 20173451609
77
One-time use of Y-type connecting valve
Shenzhen benefits heart of new medical technology Co., Ltd.
Guoliang injection standard 20173771610
78
One-time use of three-way valve
Kanglai Fang Wenzhou Medical Plastic Co., Ltd.
Guoliang injection standard 20173661611
79
Disposable pressure extension tube
Constant one (Beijing) Medical Technology Co., Ltd.
Guoliang injection standard 20173661612
80
Disposable anti-acupuncture needle indwelling needle
Suzhou Linhua Medical Devices Co., Ltd.
State equipment injection standard 20173151613
81
Human papilloma virus (HPV) nucleic acid detection and genotyping kit (PCR capillary electrophoresis fragment
Analysis)
Ningbo Haier Shi Gene Technology Co., Ltd.
Guoliang injection standard 20173403364
82
Lumen capture system
First Health Technology (Shenzhen) Co., Ltd.
State equipment injection standard 20173773365
83
Acellular dermal matrix
Jiangsu Youchuang Biomedical Technology Co., Ltd.
State equipment registered at 20173643366
84
Medical Vaseline dressing
Qingdao Teng Biotechnology Co., Ltd.
Guoliang equipment registration 20173643367
85
Disposable intravenous catheter
Yangpu Medical (Hunan) Co., Ltd.
State equipment injection standard 20173153368
86
Aortic stent graft system
First Health Technology (Shenzhen) Co., Ltd.
State apparatus is directed at 20173463369
87
Anatomy plate and supporting screws
Changzhou Iowa Medical Devices Co., Ltd.
State equipment registration standard 20173463370
88
Anatomy plate and supporting screws
Changzhou Iowa Medical Devices Co., Ltd.
State equipment injection standard 20173463371
89
Negative pressure drainage package
Wuhan Wisconsin Medical Technology Co., Ltd.
State equipment registered at 20173663372
90
Vaseline medical gauze dressing
Shenzhen Yuanxing Nano Pharmaceutical Technology Co., Ltd.
State equipment registered at 20173643373
91
One-time use pen insulin needle
Top Medical Technology (Kunshan) Co., Ltd.
Guoliang injection standard 20173153374
92
One-time use of negative pressure drainage set
Suzhou Yuan Wo Medical Devices Co., Ltd.
Guoliang injection standard 20173663375
93
Human papillomavirus (HPV) 6/11/16/18 detection kit (fluorescence PCR method)
Xiamen Aide Biomedical Technology Co., Ltd.
State equipment registered at 20173403376
94
Human papilloma virus (HPV) nucleic acid detection and genotyping kit
(Fluorescent PCR method)
Xiamen Aide Biomedical Technology Co., Ltd.
Guoliang injection standard 20173403377
95
High-risk human papillomavirus (HPV) nucleic acid detection kit (fluorescence PCR method)
Xiamen Aide Biomedical Technology Co., Ltd.
Guoliang injection standard 20173403378
96
Carbohydrate Antigen 15-3 (CA15-3) Assay Kit (Chemiluminescence Method)
Shanghai Branch Hua Biological Engineering Co., Ltd.
Guoliang injection standard 20173403379
The third type of medical equipment imports
97
Drainage catheters and accessories
ARGON MEDICAL DEVICES INC.
State equipment into 20173662466
98
Disposable automatic biopsy needle
Medax S.r.I. Unipersonale
State equipment into 20173152467
99
Blood flow-guided embolization equipment
Micro Therapeutics, Inc. DBA ev3 Neurovascular
State equipment into 20173772468
100
Hip Replacement System Components - Biconical screw cannula liner and ceramic femoral head
Smith & Nephew Orthopedics AG
State equipment into 20173462469
101
Dental adhesive
Ivoclar Vivadent AG
State equipment into 20173632470
102
Disposable sterile needles
SPIDENT Co., Ltd.
Guo Zhi injection into 20173152471
103
Ray beam scanning measurement system
IBA Dosimetry GmbH
State equipment into 20173322472
104
Ultrasound diagnostic apparatus
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
State equipment into the 20173232473
105
Semiconductor laser treatment machine
LUMENIS LIMITED
State equipment into 20173242474
106
Water isolated argon ablation catheter
ERBE Elektromedizin GmbH
Guo Zhi injection into 20173252475
107
Hepatitis C virus serotyping quality control
Simex Corporation
State equipment into the 20173402488
108
Hepatitis B virus surface antibody detection kit (Electrochemiluminescence)
Roche Diagnostics GmbH
State equipment into the 20173402489
109
Allergen-Specific IgE Antibody Test Kit (Western Blotting)
MEDIWISS Analytic GmbH
State equipment into 20173403363
110
Silicone Adhesive Edge Polyurethane Foam Dressing
LABORATOIRES URGO
State equipment into the 20173645273
111
Automatic biopsy system
Medax S.r.l Unipersonale
State equipment into the 20173155274
112
Guide catheter
Boston Scientific Corporation
State equipment into the 20173775275
113
Implantable cardiac contractility regulators
Motorika Medical (Israel) Ltd.
State equipment into the 20173215276
114
In vitro charger
Motorika Medical (Israel) Ltd.
State equipment into the 20173215277
115
Oral and maxillofacial cone beam computed tomography system
HDX WILL CORP.
Guo Zhi injection into 20173305278
116
High-frequency jet breathing machine
CARL REINER GMBN
State equipment into 20173545279
117
Pseudocyst drainage stent
Medi-Globe GmbH
State equipment into the 20173465280
118
Disposable semi-automatic biopsy needle
Medax S.r.l.Unipersonale
State equipment into the 20173155281
Imports of second-class medical equipment
119
Glycated hemoglobin analyzer
Lite-Technology Co., Ltd. Jianxing Branch Park Branch
State equipment note allowed 20172402263
120
Root canal file
MAILLEFER INSTRUMENTS HOLDING SARL
State equipment into 20172062433
121
Dental ceramics
DENTSPLY Ceramco
State equipment into 20172632434
122
Disposable medical laryngeal mask
Cookgas LLC
Guo Zhi injection into 20172662435
123
Bone guide
Medtronic Sofamor Danek USA, Inc.
Guo Zhi injection into 20172102436
124
Dental Casting Alloy
SRL Dental GmbH
State equipment into 20172632437
125
Root canal lubricant
(주) 메디 클 러스
State equipment into 20172632438
126
Implant surgery with dental drill
A.B. Dental Devices Ltd.
State equipment into 20172552439
127
Silicone rubber impression material
Müller-Omicron GmbH & Co. KG
State equipment into 20172632440
128
Dental diamond wheel pin
Jota AG
State equipment into 20172552441
129
Urodynamic catheter
Laborie Medical Technologies Canada ULC
State equipment into 20172662442
130
Urodynamics connection tube
Laborie Medical Technologies Canada ULC
State equipment into 20172662443
131
Slides
Zimmer Surgical, Inc.
State equipment into the 20172162444
132
Stoma pocket
B. Braun Medical SAS
State equipment into 20172662445
133
Extracerebral drainage bag
Sewoon Medical Co., Ltd
State equipment into the 20172642446
134
Laparoscopic surgical instruments bag hanging
ミ ズ ホ 株式会社
State equipment into 20172222447
135
Saw blade
Stryker Instruments
Guo Zhi injection into 20172102448
136
Natural latex rubber condom
한국라 텍스 공업 ㈜
State equipment into 20172662449
137
Ultrasound treatment instrument
EMS Physio Ltd.
State equipment into the 20172232450
138
Vertical pressure steam sterilizer
Pingshan Co., Ltd.
State equipment into 20172572451
139
Ultrasound bone densitometer
Osteosys Co., Ltd
State equipment into 20172232452
140
Non-invasive blood pressure wireless measuring instrument
Philips Medizin Systeme Boeblingen GmbH
State equipment into 20172212453
141
Pulse oximetry wireless meter
Philips Medizin Systeme Boeblingen GmbH
State equipment into 20172212454
142
Automatic blood cell analyzer
Japan Optoelectronics Industry Co., Ltd.
State equipment into the 20172402455
143
Medical warming blanket
R & L Co., Ltd.
State equipment into 20172582456
144
Audiometer
Rion Co., Ltd.
State equipment into 20172212457
145
Acoustic impedance meter
Rion Co., Ltd.
State equipment into 20172212458
146
ENT comprehensive treatment Taiwan
ATMOS Medizin Technik GmbH & Co. KG
State equipment into 20172542459
147
Body composition analyzer
InBody Co., Ltd.
State equipment into 20172212460
148
Automatic biochemical analyzer
Beckman Coulter, Inc.
Guo Zhi injection into 20172402461
149
Electronic image processor
Fuji Filmer Co., Ltd.
State equipment into 20172222462
150
Chloride electrode
Hitachi High-Technologies Co., Ltd.
State equipment into 20172402463
151
Ultrasound image quantification software
Philips Ultrasound, Inc.
State equipment into the 20172702464
152
Progesterone calibration solution
Roche Diagnostics GmbH
State equipment into the 20172402465
153
laryngoscope
WELCH ALLYN, INC.
State equipment into 20172222476
154
LED light curing machine
3M Deutschland GmbH
State equipment into 20172552477
155
Vacuum suction pump
Medela AG
Guo Zhi injection into 20172542478
156
Battery Powered Bone Tissue Surgical Equipment
ConMed Corporation
Guo Zhi injection into 20172102479
157
ENT comprehensive treatment Taiwan
dantschke MEDIZINTECHNIK GmbH & Co. KG
State equipment into 20172542480
158
Bipolar coagulation forceps
Aesculap AG
State equipment into 20172252481
159
Flow cytometry
Becton, Dickinson and Company, BD Biosciences
State equipment into the 20172402482
160
Blood glucose meter
i-SENS, Inc.
State equipment into 20172402483
161
Dental phosphate acid etching agent
METABIOMED CO., LTD
State equipment into 20172632484
162
Application
Co., Ltd. Ruiguangmeidali
State equipment into the 20172642485
163
Medical pressure belt
Medi GmbH & Co.KG
Guo Zhi injection into 20172642486
164
Atomization spray device
Salter Labs
State equipment into 20172662487
165
Programmable controller
Motorika Medical (Israel) Ltd.
State equipment into 20172215270
166
Disposable heat and moisture exchanger
Ju Bang Medical Material Co., Ltd.
Guo Zhi Note Xu 20172665271
167
Metal self-ligating bracket
Tomy Co., Ltd.
State equipment into 20172635272
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