Verification storm, Roche and other equipment to withdraw a large number of 169 large number of applications

January 3, 2016 A total of 169 applications were withdrawn by 261 companies from December 13, 2016 to December 15, 2017. Of these, 42 companies withdrew 105 applications for registration of in-vitro diagnostic reagents ( Table 1), 127 companies withdrew 156 other medical device registration applications (Table 2).
Table 1: Withdrawal of IVD Application Register
Serial number
Acceptance number
product name
applicant
1
Into 15-4466
Squamous cell carcinoma antigen test kit (Electrochemiluminescence)
Roche Diagnostics GmbH
2
More 20151502
Lipase test kit (colorimetric method)
Roche Diagnostics GmbH
3
Into 15-4050
Acetaminophen assay kit (homogeneous enzyme immunoassay
Roche Diagnostics GmbH
4
JSZ1600061
Carbamazepine test kit (homogeneous enzyme immunoassay)
Roche Diagnostics GmbH
5
More 20151928
Placenta Growth Factor Assay Kit (Electrochemiluminescence)
Roche Diagnostics GmbH
6
More 20151926
Soluble fms like tyrosine kinase-1 test kit (Electrochemiluminescence)
Roche Diagnostics GmbH
7
JSY1600951
Inorganic phosphorus detection kit (UV method)
Randox Laboratories Ltd.
8
JSY1601147
Triglyceride Assay Kit (GPO-PAP)
Randox Laboratories Ltd
9
JSY1601151
Direct bilirubin detection kit (colorimetric method)
Randox Laboratories Ltd.
10
Standard 15-2585
Human Immunodeficiency Virus (HIV1 + 2) Antibody Test Kit (Time-Resolved Immunofluorescence)
Suzhou New Wave Biological Technology Co., Ltd.
11
Quasi 15-2572
Human Immunodeficiency Virus Antigen Antibody (HIV Ag / Ab) Assay Kit (Time-resolved Immunofluorescence)
Suzhou New Wave Biological Technology Co., Ltd.
12
Standard 15-0556
Herpes Simplex Virus (HSV) 1 + 2 Nucleic Acid Assay Kit (PCR-Fluorescent Probe Method)
Guangzhou Huayin Pharmaceutical Technology Co., Ltd.
13
Standard 14-5230
Human RET gene fusion detection kit (fluorescence PCR method)
Xiamen Aide Biomedical Technology Co., Ltd.
14
JSZ1600019
Sirolimus test kit (Electrochemiluminescence)
Roche Diagnostics GmbH
15
Standard 14-5244
Bordetella pertussis IgG antibody test kit (ELISA)
Beijing Bell Biological Engineering Co., Ltd.
16
Standard 15-3078
Mycobacterium tuberculosis drug resistance gene test kit (PCR-fluorescence probe method)
Boao Biological Group Co., Ltd.
17
JSZ1600038
Tissue peptide antigen assay kit (enzyme-linked immunosorbent assay)
IDL Biotech AB (publ)
18
Into 15-3909
Hepatitis B virus surface antibody detection kit (Electrochemiluminescence)
Roche Diagnostics GmbH
19
Into 15-4464
EBER probe (in situ hybridization)
Roche Diagnostics GmbH
20
JSZ1600020
Anti-phosphatidyl serine antibody IgA detection kit (enzyme-linked immunosorbent assay)
EUROIMMUN Medizinische Labordiagnostika AG
21
JSZ1600021
Anti-phosphatidyl serine antibody IgA / G / M detection kit (enzyme-linked immunosorbent assay)
EUROIMMUN Medizinische Labordiagnostika AG
22
JSZ1600022
Anti-phosphatidyl Serine Antibody IgG Assay Kit (Enzyme-Linked Immunosorbent Assay)
EUROIMMUN Medizinische Labordiagnostika AG
23
JSZ1600023
Anti-phosphatidyl serine antibody IgM detection kit (enzyme-linked immunosorbent assay)
EUROIMMUN Medizinische Labordiagnostika AG
24
Quasi 15-3091
Human CYP2C19 genotyping kit (primer-specific extension method)
Taipu Biological Sciences (China) Co., Ltd.
25
JSZ1600081
Hematopoietic Stem Cell Antigen CD34 Assay Kit (Flow Cytometry)
Becton, Dickinson and Company, BD Biosciences;
26
JSY1700197
α-1 Acid Glycoprotein Assay Kit (Immunoturbidimetry)
Randox Laboratories Ltd.
27
CSY1600577
Carcinoembryonic Antigen (CEA) Quantitation Assay Kit (Enzyme-Linked Immunosorbent Assay)
Beijing is Dan international technology limited liability company
28
CSY1600579
Total prostate specific antigen (tPSA) quantitative assay kit (enzyme-linked immunosorbent assay)
Beijing is Dan international technology limited liability company
29
CSY1600578
AFP (AFP) Quantitative Assay Kit (Enzyme Linked Immunosorbent Assay)
Beijing is Dan international technology limited liability company
30
Standard 15-1904
Hepatitis C virus genotyping test kit (PCR-fluorescence probe method)
Hunan Shengxiang Biological Technology Co., Ltd.
31
JSX1600053
Human epididymal protein 4 calibration solution
Roche Diagnostics GmbH
32
CSY1600047
Hepatitis B virus nucleic acid quantitative detection kit (PCR-fluorescence probe method)
Zhengyuan Shengbang (Tianjin) Biological Technology Co., Ltd.
33
Quasi 15-2217
Genitourinary tract infection 6 joint detection kit (gene chip method)
Kunming Huanchi Biochip Industry Co., Ltd.
34
Quasi 15-2219
Human Papillomavirus Genotyping Assay Kit (Gene Chip)
Kunming Huanchi Biochip Industry Co., Ltd.
35
JSX1700094
Ferritin Assay Kit (Immunoturbidimetry)
Randox Laboratories Ltd.
36
JSX1700046
Rheumatoid factor test kit (latex enhanced immune turbidimetric method)
Randox Laboratories Ltd.
37
Standard 15-3109
MTRR A66G gene detection kit (PCR-gold magnetic particle chromatography)
Xi'an Golden Magnetic nano-Biotechnology Co., Ltd.
38
JSZ1600093
Cortisol Assay Kit (Chemiluminescence Immunoassay)
DiaSorin S.p.A.
39
CSZ1600180
Human Immunodeficiency Virus Antigen and Antibody (HIV Ag / Ab) Assay Kit (Magnetic Particle Chemiluminescence)
Jiangsu Zecheng Biotechnology Co., Ltd.
40
CSZ1600198
Tumor Associated Antigen CA125 Assay Kit (Chemiluminescence Immunoassay)
Beijing Tongsheng Biotech Co., Ltd.
41
CSZ1600088
Human CYP2C19 Gene Polymorphism Test Kit (Fluorescent PCR-Melting Curve Method)
Guangzhou good Chi Biological Technology Co., Ltd.
42
CSZ1600087
Human MTHFR Gene Polymorphism Test Kit (Fluorescent PCR-Melting Curve Method)
Guangzhou good Chi Biological Technology Co., Ltd.
43
Into 15-4145
Upper respiratory tract infectious agents nucleic acid detection kit (nested multiplex PCR melting curve method)
BioFire Diagnostics, LLC
44
Standard 15-2660
BRAF gene mutation detection kit (PCR-sequencing method
Zhongshan University Daan Gene Co., Ltd.
45
Standard 15-3092
MTHFR A1298C gene detection kit (PCR-gold magnetic particle chromatography)
Xi'an Golden Magnetic nano-Biotechnology Co., Ltd.
46
Standard 15-2609
Morphine, methamphetamine, ketamine combined detection kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
47
Standard 15-2621
Morphine, methamphetamine, methadone test kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
48
Standard 15-2613
Morphine, methamphetamine, ketamine, MDMA, methadone detection kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
49
Standard 15-2624
Tetrahydrocannabinol test kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
50
Quasi 15-2611
Morphine, methamphetamine, ketamine, DHEA, tetrahydrocannabinol combined detection kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
51
Standard 15-2607
Buprenorphine test kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
52
Quasi 15-2608
Methadone test kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
53
Standard 15-2610
Benzodiazepine detection kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
54
Standard 15-2615
Morphine, Methamphetamine, Ketamine, Cocaine, Diammonite Amphetamine Saliva Joint Detection Kit (Colloidal Gold Method)
Hangzhou Anxu Technology Co., Ltd.
55
Standard 15-2622
Amphetamine test kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
56
CSZ1600187
Treponema pallidum antibody test kit (chemiluminescence)
Shenzhen Ya Hui Long Biological Technology Co., Ltd.
57
Quasi 15-3211
Hepatitis C virus (HCV) genotyping test kit (PCR-fluorescence probe method)
Shanghai Promega Biological Products Co., Ltd.
58
CSZ1600048
Hepatitis B virus (HBV) genotyping test kit (PCR-fluorescence probe method)
Shanghai Promega Biological Products Co., Ltd.
59
Quasi 15-2628
Morphine, methamphetamine, ketamine saliva joint detection kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
60
Quasi 15-2627
Morphine, methamphetamine, ketamine, cocaine, dimethylenediamine amphetamine, tetrahydrocannabinol combined detection kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
61
Standard 15-2625
Cocaine detection kit (colloidal gold method)
Hangzhou Anxu Technology Co., Ltd.
62
Standard 15-2623
Diamine Diamine Amphetamine Test Kit (Gold Colloid Method)
Hangzhou Anxu Technology Co., Ltd.
63
JSY1600393
Toxoplasma gondii IgG / IgM antibody detection kit (enzyme-linked immunosorbent assay)
bioMerieux, SA
64
Standard 15-3172
Stool occult blood - Helicobacter pylori antigen combined detection reagent (immunochromatography)
Guangzhou Wan Fu Biotechnology Co., Ltd.
65
CSY1700265
Herpes simplex virus type I IgM antibody detection kit (chemiluminescence)
Zhengzhou Fu Bi 赛 Biotechnology Co., Ltd.
66
CSY1700271
Rubella virus IgM antibody detection kit (chemiluminescence method)
Zhengzhou Fu Biosai Biotechnology Co., Ltd.
67
CSY1700270
Toxoplasma gondii IgG antibody detection kit (chemiluminescence)
Zhengzhou Fu Biosai Biotechnology Co., Ltd.
68
CSY1700269
Toxoplasma gondii IgM antibody detection kit (chemiluminescence)
Zhengzhou Fu Bi 赛 Biotechnology Co., Ltd.
69
CSY1700264
Cytomegalovirus IgG antibody detection kit (chemiluminescence method)
Zhengzhou Fu Bi 赛 Biotechnology Co., Ltd.
70
CSY1700263
Cytomegalovirus IgM antibody detection kit (chemiluminescence method)
Zhengzhou Fu Bi 赛 Biotechnology Co., Ltd.
71
CSY1700272
Rubella virus IgG antibody detection kit (chemiluminescence)
Zhengzhou Fu Bi 赛 Biotechnology Co., Ltd.
72
CSY1700268
Herpes simplex virus type 2 IgG antibody detection kit (chemiluminescence)
Zhengzhou Fu Bi 赛 Biotechnology Co., Ltd.
73
CSY1700267
Herpes simplex virus type IgM antibody detection kit (chemiluminescence)
Zhengzhou Fu Biosai Biotechnology Co., Ltd.
74
CSY1700266
Herpes simplex virus type I IgG antibody detection kit (chemiluminescence)
Zhengzhou Fu Biosai Biotechnology Co., Ltd.
75
CSY1700375
Hepatitis B Virus Surface Antibody (HBsAb) Assay Kit (Chemiluminescence)
Beijing Dacheng Biological Engineering Co., Ltd.
76
CSY1700376
Hepatitis B virus core antibody (HBcAb) assay kit (chemiluminescence)
Beijing Dacheng Biological Engineering Co., Ltd.
77
CSZ1600132
Ketamine saliva test kit (colloidal gold method)
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
78
CSZ1600134
Methamphetamine / ketamine combined saliva test kit (colloidal gold method)
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
79
CSZ1600130
Methamphetamine saliva test kit (colloidal gold method)
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
80
CSZ1600128
Morphine saliva test kit (colloidal gold method)
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
81
CSZ1600126
Cocaine detection kit (colloidal gold method)
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
82
CSZ1600125
Diamine Diamine Amphetamine Test Kit (Gold Colloid Method)
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
83
CSZ1600123
Tetrahydrocannabinol test kit (colloidal gold method)
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
84
CSZ1600133
Morphine / methamphetamine / ketamine combined saliva test kit (colloidal gold method)
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
85
CSZ1600135
Morphine / Methamphetamine / Dimethylamine Dioxetamine / Ketamine / Tetrahydrocannabinol Combined Assay Kit (Colloidal Gold Method
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
86
CSZ1600124
Morphine / Methylamphetamine / Ketamine Combination Assay (Colloidal Gold Method)
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
87
JSX1600333
A number of biochemical calibrators
Beckman Coulter, Inc.
88
CSZ1600113
Toxoplasma gondii IgG antibody detection kit (microcolumn gel method)
Changchun Bo Xun biotechnology limited liability company
89
CSY1600536
Plasmodium falciparum antigen detection reagent (colloidal gold method)
Aibo Biomedicals (Hangzhou) Co., Ltd.
90
CSY1600535
Plasmodium falciparum / Plasmodium vivax antigen detection reagent (colloidal gold method)
Aibo Biomedicals (Hangzhou) Co., Ltd.
91
CSZ1600136
Morphine / Methylamphetamine / Dimethylenediamine Amphetamine / Ketamine / Tetrahydrocannabione / Cocaine Joint Detection Reagents
Xiamen Zhongsheng Longjie Biotechnology Co., Ltd.
92
CSY1700046
Human immunodeficiency virus (HIV 1/2) antibody detection kit (colloidal gold method)
Beijing Jian Nai Xi Biotechnology Co., Ltd.
93
CSZ1600140
α-L-Fucosidase Assay Kit (continuous monitoring method)
Ningbo Saikai Biotechnology Co., Ltd.
94
CSX1700077
Carbohydrate antigen 50 assay kit (chemiluminescence immunoassay)
Jiangsu Fulong Biotechnology Co., Ltd.
95
CSX1700075
Human epididymal epithelial secreted protein 4 assay kit (chemiluminescence immunoassay)
Jiangsu Fulong Biotechnology Co., Ltd.
96
CSX1700074
Ferritin Assay Kit (Chemiluminescence Immunoassay)
Jiangsu Fulong Biotechnology Co., Ltd.
97
JSY1700339
Human calcitonin detection kit (enzyme-linked immunosorbent assay)
BIOMERICA, INC.
98
JSY1700340
Human whole parathyroid hormone test kit (enzyme-linked immunosorbent assay)
BIOMERICA, INC.
99
CSY1700395
Diamine Diamine Amphetamine Test Kit (Gold Colloid Method)
Zhengyuan Shengbang (Tianjin) Biological Technology Co., Ltd.
100
CSZ1600079
Hepatitis C virus nucleic acid quantitative detection kit (fluorescence PCR method)
Jiangsu Master Biotech Co., Ltd.
101
CSZ1700159
Candida universal nucleic acid detection kit (fluorescence PCR method)
Blue Blue Hangzhou Biological Technology Co., Ltd.
102
CSZ1600040
Folic acid-related gene polymorphism detection kit (PCR fluorescence probe method)
Shanghai source odd biomedical Technology Co., Ltd.
103
CSZ1600038
Clopidogrel-related gene polymorphism detection kit (PCR fluorescence probe method)
Shanghai source odd biomedical Technology Co., Ltd.
104
Into 15-4169
Anti-Toxoplasma IgG IgG Affinity Assay Kit (Enzyme-Linked Immunosorbent Assay)
Medizinische Labordiagnostika AG
105
Quasi 15-2423
MTHFR and MTRR gene polymorphism detection kit (fluorescence PCR melting curve method)
Xiamen Zhi Shan Biotechnology Co., Ltd.
Table 2: Withdrawal of other medical device registration application list
Serial number
Acceptance number
product name
applicant
1
Into 15-2384
Hollow fiber dialyzer (trade name: TORAYLIGHT)
Toray Co., Ltd.
2
Into 15-2678
Multi-wavelength laser treatment instrument
ASA s.r.l.
3
Into 15-2671
Multi-wavelength laser treatment instrument
ASA s.r.l.
4
CQX1600321
Vacuum closed drainage dressings pipeline package
Chengdu Jitai Medical Devices Co., Ltd.
5
Into 15-3078
Vial adapter
Medimop Medical Projects Ltd.
6
CQY1600027
Rapamycin drug eluting branching system
Le Pu (Beijing) Medical Devices Co., Ltd.
7
CQZ1600254
Bacterial cellulose antibacterial material
Beijing Ding Han Heng Hai Biotechnology Co., Ltd.
8
CQZ1600051
High potential therapeutic apparatus
Guangzhou Yihe Medical Technology Development Co., Ltd.
9
Quasi 15-2259
Disposable invasive pressure sensor
Shenzhen Mindray Biomedical Electronics Co., Ltd.
10
More 20151185
Dental digital impression machine
Ormco Corporation
11
Into 15-0109
Spray cans and components
Chongren Technology Co., Ltd.
12
More 20151930
IOL folder
ABBOTT MEDICAL OPTICS INC.
13
Into 15-3007
Portable near infrared rapid intracranial hemorrhage detector
Infrascan, Inc.
14
CQZ1600258
Hemodialysis concentrate (trade name: concentrated dialysis solution, dialysis powder)
Ruipeng Medical Devices Chengdu Co., Ltd.
15
More 20151682
Patient monitor
Space Medical Instruments (Suzhou) Co., Ltd.
16
Standard 15-1039
Plug plastic
Beijing Kang Pat Medical Devices Co., Ltd.
17
Quasi 15-1031
Ear brain glue
Beijing Kang Pat Medical Devices Co., Ltd.
18
Standard 15-1059
Hemostatic closed plastic
Beijing Kang Pat Medical Devices Co., Ltd.
19
JQX1600556
Implantable ECG event monitor
Medtronic Inc.
20
Quasi 15-1432
Inhalation sedation analgesic injection system
Shenzhen Security Technology Co., Ltd.
21
CQX1700009
Ventricular septal defect occluder
First Health Technology (Shenzhen) Co., Ltd.
22
More 20151834
Patch
Johnson & Johnson International, c / o European Logistics Center
23
JQX1600008
High-pressure injection system
Bayer Medical Care Inc.
24
JQZ1600532
Blood lipid analyzer
SD Biosensor, Inc.
25
Into 15-2741
Revision femoral stem system
Smith & Nephew, Inc.
26
Quasi 15-2555
Single-use catheter sheath group
Zhejiang sea St. Medical Devices Co., Ltd.
27
Standard 15-2534
One-time use of ring handle syringe
Zhejiang sea St. Medical Devices Co., Ltd.
28
Into 14-3797
Bone cement
Heraeus Medical GmbH
29
CQX1600173
Polyvinyl alcohol embolism microspheres
Suzhou Heng Rui Jia Li Sheng Biomedical Technology Co., Ltd.
30
JQX1600229
Dural patch
Codman & Shurtleff, Inc.
31
Into 15-2040
Gamma ray detection system
DILON TECHNOLOGIES INC.
32
Quasi 15-2366
One-time use of peripheral nerve plexus stimulation package
Zhejiang Su Jia Medical Devices Co., Ltd.
33
Into 15-2675
Nd: YAG laser treatment instrument
DEKA M.E.L.A.Srl
34
More 20151683
Ventilator
Newbond Medical Equipment Co., Ltd.
35
CQZ1600399
Brain Fluctuation Chart Instrument
Guangzhou Kefu Medical Technology Co., Ltd.
36
JQX1600394
Scan laser ophthalmoscope
EasyScan B.V.
37
More 20151622
One-step puncture drainage kit
Merit Medical Systems, Inc.
38
JQX1600140
Real-time fluorescence quantitative PCR instrument
Life Technologies Holdings Pte Ltd
39
CQY1600764
Metal plate (angle bone plate)
Changzhou Kang Hui Medical Devices Co., Ltd.
40
JQX1600830
Appliance
Align Technology, Inc.
41
JQY1601850
One-time use of umbilical cord blood bags
CESCA THERAPEUTICS INC dba THERMOGENESIS CORP.
42
CQZ1700113
Ankle system
Dabo Medical Technology Co., Ltd.
43
Quasi 15-3191
Hemodialysis A dry powder hemodialysis B dry powder
Jiangxi Hongda Medical Devices Group Co., Ltd.
44
Standard 15-3182
Hemodialysis A Concentrate Hemodialysis B Concentrate
Jiangxi Hongda Medical Devices Group Co., Ltd.
45
JQX1600306
Artificial knee joint system
DePuy Orthopedics, Inc.
46
JQZ1600209
Balloon dilatation catheter
NuMED, Inc.
47
JQZ1500002
Block the balloon catheter
Stryker Neurovascular
48
JQZ1600251
UV illuminator
Cerus Europe B.V.
49
More 20151875
Ultrasound diagnostic system
ESAOTE S.p.A.
50
More 20151876
Ultrasound diagnostic system
ESAOTE S.p.A.
51
More 20151869
Ultrasound diagnostic system
ESAOTE S.p.A.
52
Standard 15-3162
A crystalline eye room refractive lenses
Hangzhou love crystal Lun Technology Co., Ltd.
53
JQX1600425
Metal brackets
TP Orthodontics, Inc.
54
CQZ1600170
Polyurethane foam dressings
Jiangsu Nova Medical Supplies Co., Ltd.
55
CQX1600126
Nano silver medical antibacterial dressing
Shenzhen Ai Jie Te Pharmaceutical Technology Co., Ltd.
56
CQX1600127
Nano-silver antibacterial self-adhesive medical paste
Shenzhen Ai Jie Te Pharmaceutical Technology Co., Ltd.
57
Into 14-3535
ARES ™ antibiotics impregnate ventricles and abdominal catheters
Medtronic Inc.
58
CQX1700053
High-voltage potential treatment instrument
Nanjing Tangwo Medical Technology Co., Ltd.
59
JQY1600893
Guide catheter
Invatec S.p.A
60
CQX1700071
Disposable infusion set with needle
Beijing Volta Technology Co., Ltd.
61
Into 15-3685
Spinal fixation system
Spinal fixation system
62
CQZ1600193
Single-use intravenous infusion bag
Shandong Weigao Group Medical Polymer Co., Ltd.
63
CQZ1600327
Synthetic resin teeth
Hill eight tooth industry (Changshu) Co., Ltd.
64
QF2015000013
Oral disposable needles
NOVOCOL PHARMACEUTICAL OF CANADA INC.
65
CQZ1600032
Cruise capsule endoscope control system
Shanghai An Han Medical Technology Co., Ltd.
66
Quasi 15-2657
Soft hyperbaric chamber
Mu Mu International Hi-Tech (Beijing) Co., Ltd.
67
CQX1600304
Implantable drug delivery device
Shijiazhuang Nuo Er Kang Medical Devices Co., Ltd.
68
CQZ1600383
Ventilator
Zibo Branch Chong Medical Instruments Co., Ltd.
69
CQZ1600384
Ventilator
Zibo Branch Chong Medical Instruments Co., Ltd.
70
CQZ1700162
One-time use of contrast catheters
Zhejiang sea St. Medical Devices Co., Ltd.
71
JQY1700146
RF electrode
inomed Medizntechnik GmbH
72
JQY1700145
Stimulate the recording electrode
inomed Medizintechnik GmbH
73
CQZ1600495
X-ray computed tomography equipment
Aotai Medical System Co., Ltd.
74
CQZ1700149
High-pressure balloon dilatation catheter
Zhejiang sea St. Medical Devices Co., Ltd.
75
CQZ1700148
PTCA balloon dilatation catheter
Zhejiang sea St. Medical Devices Co., Ltd.
76
JQX1700330
Titanium base Taiwan
DENTSPLY Implants Manufacturing GmbH
77
JQX1700331
Dental implants
DENTSPLY Implants Manufacturing GmbH
78
JQX1700328
Gold alloy base and accessories
DENTSPLY Implants Manufacturing GmbH
79
JQX1700329
Implant system accessories
DENTSPLY Implants Manufacturing GmbH
80
JQX1600922
Wound cleaning liquid dressings
NovaBay Pharmaceuticals, Inc.
81
CQX1600050
Disposable precision filter infusion
Xuancheng Jiangnan Medical Devices Co., Ltd.
82
JQZ1600025
Coil
Medos International SARL
83
JQX1600058
Single-use injection RF electrodes
Cosman Medical, Inc.
84
JQZ1600148
High-performance guide wire
NeoMetrics, Inc.
85
JQY1600847
Ultrasonic cleaning equipment (Product Name: Chinese: Barryos 970 Original: Varios970)
Nakanishi Co., Ltd.
86
Standard 15-1865
Patent foramen ovale occluder
First Health Technology (Shenzhen) Co., Ltd.
87
JQZ1600111
Stone removers
ENDO-FLEX GmbH
88
CQX1700116
High-voltage potential treatment instrument
Nanjing Tangwo Medical Technology Co., Ltd.
89
JQX1600593
Power System (trade name: EMax 2 Plus System)
The Anspach Effort, Inc.
90
JQZ1600018
Zinc oxide eugenol cement
Produits Dentaires SA
91
JQZ1700061
Prefilled syringe connector
Transcoject GmbH
92
CQZ1700091
One-time use of contrast catheter indwelling needle
Terumo medical products (Hangzhou) Co., Ltd.
93
Standard 15-2123
Needleless syringe
Jiangsu Cheng-yu Mitt Medical Technology Co., Ltd.
94
CQZ1600276
Amniotic lacrimal repair scaffold
Jiangxi Rui Ji Biological Engineering Technology Co., Ltd.
95
CQZ1600324
Hydrogen atomizer
Shanghai 潓 US Medical Technology Co., Ltd.
96
JQX1600666
Intracranial pressure monitoring system attachment
Codman & Shurtleff, Inc.
97
JQZ1600201
Rinse the tube once
TAVTECH Ltd.
98
CQZ1700230
Dialysis dry powder
Friends of Friends of Sichuan kidney Technology Co., Ltd.
99
CQZ1700218
Dialyzed concentrate
Friends of Friends of Sichuan kidney Technology Co., Ltd.
100
CQZ1700105
Disposable infusion set with needle
Jiangsu Zhi Yu Medical Equipment Co., Ltd.
101
JQZ1500007
Intervertebral fusion
Jie Mai (Shanghai) Medical International Trade Co., Ltd.
102
Quasi 15-3047
Endovascular stent release
Beijing Yuheng Jia Technology Co., Ltd.
103
Standard 15-2831
Endovascular stent
Beijing Yuheng Jia Technology Co., Ltd.
104
JQZ1600243
Capsule endoscope recorder and image processing system
Given Imaging Inc.
105
JQX1600841
One-time use of closed suction device (adult turbo cleaning catheter)
Halyard Health, Inc.
106
JQX1600842
One-time use of closed suction device
Halyard Health, Inc.
107
CQZ1700231
Argon high-frequency knife
Shandong Yuhua Electric Co., Ltd.
108
CQZ1600376
Disposable intravenous catheter
Shenzhen Shun US Medical Co., Ltd.
109
Into 15-3954
Pen-type syringe
BD Medical - Pharmaceutical Systems
110
CQZ1700163
Plasma surgery system
Top Energy (Tianjin) Technology Co., Ltd.
111
Into 14-3037
Implant
BICON, LLC.
112
JQY1600712
ECG machine
Welch Allyn Limited
113
CQZ1700296
One-time ultrasonic cutting hemostatic knife
Tianjin Ricky Surgical Instruments Co., Ltd.
114
JQX1700028
High-frequency electric knife system
CooperSurgical, Inc.
115
CQZ1700037
Iodine protection cap
Wuhu Road Run medicine limited liability company
116
JQZ1600316
Electronic endoscope
Fujifilm Corporation
117
More 20150236
Anti-blocking medical modified chitosan (film) (trade name: Pomelo)
Beijing Bailey Kang Biochemical Co., Ltd.
118
CQX1700156
Real-time fluorescence quantitative PCR instrument
Card You Di Biological Technology (Beijing) Co., Ltd.
119
More 20151872
Corneal lamellar knife
Med-Logics, Inc.
120
CQX1700088
Anesthesia Machine
Beijing Yi An Medical System Co., Ltd.
121
JQZ1600457
Total absorption of biological vascular stent system
Abbott Medical Devices Trading (Shanghai) Co., Ltd
122
JQY1701304
Support catheter
Bard Peripheral Vascular, Inc.
123
JQY1700104
High-pressure contrast stab wound infusion needle kit
Smiths Medical ASD, Inc.
124
JQZ1600278
Uterine positioning handle
CooperSurgical, Inc.
125
JQZ1600219
Bone filling material
Collagen Matrix, Inc.
126
CQX1700261
Close after treatment equipment
Beijing Branch Lin Institute of Medical Technology
127
JQX1700470
Ultrasound high-frequency surgical integrated system ultrasound head
Ethicon Endo-Surgery, LLC
128
JQZ1700375
Arthroscopic surgical instruments
Inion Oy
129
JQY1601631
Bioabsorbable tissue repair material (trade name: GORE® BIO-A®)
W. L. Gore & Associates, Inc.
130
CQZ1600389
Brain dural impermeable medical coating system
Beijing 赛 Chico Technology Co., Ltd.
131
CQZ1700500
Axial flow auxiliary blood pump
Beijing Fuwai Medical Heart Health Technology Co., Ltd.
132
CQZ1600257
Vaseline medical gauze
Henan Province Blue Sky Medical Devices Co., Ltd.
133
CQZ1600459
Disposable plastic bag with leukocyte filter
Chongqing three great Albert Pharmaceutical Co., Ltd.
134
CQX1600102
Plasma separator
Chongqing three great Albert Pharmaceutical Co., Ltd.
135
CQZ1600180
Irrigation pump system
Shanghai minimally invasive electrophysiological Medical Technology Co., Ltd.
136
JQY1601505
Disposable transfusion
Freseniuskabi (China) Investment Co., Ltd.
137
JQZ1600125
Carbon dioxide laser treatment instrument
WON TECH Co., Ltd.
138
CQZ1700206
Disposable precision filter infusion
Sichuan Buren Medical Devices Co., Ltd.
139
JQZ1600473
Fundus macular pigment density meter
Elektron Technology UK Limited
140
JQZ1600599
Digital oral panoramic X-ray machine
Soredex, PaloDEx Group Oy
141
JQZ1700014
Dental panoramic X-ray machine
PaloDEx Group Oy
142
Into 15-2752
Absorbable surgical suture
ETHICON LLC
143
JQZ1600397
High voltage generator
United States XiBiEi Asia company Beijing office
144
JQZ1600398
High voltage generator
United States XiBiEi Asia company Beijing office
145
CQZ1700506
Automatic blood collection machine
Beijing Minas surgery Robotics Co., Ltd.
146
Standard 15-2894
Antibacterial absorbable suture
Shanghai Ruisheng Medical Devices Co., Ltd.
147
CQZ1600060
Disposable intravenous catheter
Suzhou Jinsheng Medical Products Co., Ltd.
148
CQZ1600288
Medical Magnetic Resonance Imaging System
Philips Medical (Suzhou) Co., Ltd.
149
CQZ1600340
Total knee replacement intelligent assistant system
Shandong Yi Mai Medical Technology Co., Ltd.
150
JQZ1600107
Injection pump
Eunsung Global Corp.
151
CQZ1600056
Hemodialysis catheter
Shanghai Pu Yi Medical Devices Co., Ltd.
152
JQX1700740
Tissue fixation system
Medtronic Inc.
153
CQZ1600214
Hemodialysis dry powder
Liaoning Sansheng Technology Development Co., Ltd.
154
Standard 15-2535
Hollow fiber dialyzer
Asahi Kasei Medical Devices (Hangzhou) Co., Ltd.
155
Standard 15-2536
Hollow fiber dialyzer
Asahi Kasei Medical Devices (Hangzhou) Co., Ltd.
156
Quasi 15-2530
Hollow fiber dialyzer
Asahi Kasei Medical Devices (Hangzhou) Co., Ltd.
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