June 17, 2011 import approval notice

No.
Acceptance number
Variety name
applicant
Note
1
Into 06-1294
Tracheal endoscopes and accessories
Beijing Jietong Connaught Pharmaceutical Technology Co., Ltd.
2
Jin 08-3287
Apolipoprotein A-1 Assay Kit (Immunoturbometry)
Beckman Coulter, Inc.
3
Jin 08-3288
Apolipoprotein B Assay Kit (Immunoturbometry)
Beckman Coulter, Inc.
4
Into 09-1591
Carbon Dioxide Assay Kit (Enzyme Method)
Siemens Healthcare Diagnostics Inc.
5
Into 09-2179
Direct Bilirubin Assay Kit
Prodia Diagnostics
6
Into 09-2527
Multiple protein calibration solutions
Siemens Healthcare Diagnostics Inc.
7
Into 09-3458
Cardiac stimulation system
Beijing Cheng Nuo Mei Di Technology Co., Ltd.
8
Into 09-4711
Absorbance measurement kit (endpoint method)
Siemens Healthcare Diagnostics Inc.
9
Into 10-0727
Blood glucose test strip
Bioptik Technology, Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
10
Into 10-0768
Blood glucose test strip
Bioptik Technology, Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
11
Into 10-0769
Uric acid test strip
Bioptik Technology, Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
12
Into 10-1112
Electronic chest laparoscope
Olympus (Beijing) Sales Service Co., Ltd.
13
Into 10-1258
Thyroxine calibrator
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
14
Into 10-1383
Chest compression system
US Medtronic China Co., Ltd. Beijing Office
15
Into 10-1483
Integrated expansion/crushed stone system
Poco International Medical Trading (Shanghai) Co., Ltd. Beijing Branch
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
16
Into 10-1500
Semiconductor microwave therapeutic apparatus
Beijing Weiliheng Technology Development Co., Ltd.
17
10-1740
Multiple lipids for the detection of pathological quality control products
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
18
Into 10-1805
CD38 APC (HB-7) Assay Reagent (Flow Cytometry)
BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
19
Into 10-1811
CD14 APC-Cy7 Detection Reagent (Flow Cytometry)
BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
20
Into 10-1812
CD20 APC-Cy7 Detection Reagent (Flow Cytometry)
BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
twenty one
Into 10-1955
Nerve plexus stimulation needle (D type)
Braun Medical (Shanghai) International Trading Co., Ltd. Beijing Branch
twenty two
Entering 10-1977
Free thyroid hormone/thyroid stimulant calibrator
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
twenty three
Into 10-2061
Ferritin calibrator
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
twenty four
Into 10-2115
Radiotherapy planning system
Beijing Jierujia Technology Co., Ltd.
25
Into 10-2132
Sphincter cutting knife
Poco International Medical Trading (Shanghai) Co., Ltd. Beijing Branch
26
Into 10-2226
Total triiodothyronine calibrator
Siemens Healthcare Diagnostics Inc.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
27
Into 10-2335
Insulated guide wire
Baiduli (Beijing) Medical Devices Co., Ltd.
28
Into 10-2577
Unsaturated iron binding test kit (colorimetric method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
29
Into 10-2873
Artificial hip components - bone cement stem, bone cement stopper, femoral head
United Medical Devices Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
30
Into 10-3014
Disposable waste collection bag
Aon Medical Devices Trading (Suzhou) Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
31
Into 10-3029
Shadowless light
Beijing Kevis Medical Consulting Co., Ltd.
32
Into 10-3047
Heated tooth gel filling system
Baotou Meita Dental Medical Equipment Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
33
Into 10-3079
Neurosurgery pneumatic drilling system
Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
34
Into 10-3081
2 micron laser surgery system
Beijing Health Supreme Electronics Co., Ltd.
35
Into 10-3204
Superconducting magnetic resonance imaging system
Toshiba Medical Systems (China) Co., Ltd.
36
Into 10-3261
Automatic immunoassay analyzer
Switzerland Abbott Pharmaceutical Co., Ltd. Beijing Office
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
37
Into 10-3988
Gram-positive bacteria identification/drug sensitivity plate
Becton, Dickinson and Company
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
38
Into 11-0357
Thyroglobulin antibody calibrator
Abbott Laboratories
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
39
Into 11-0398
Free Triiodothyronine Standard Calibrator
Abbott Ireland Diagnostics Division
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
40
Into 11-0399
Thyroid-stimulating hormone third-generation assay kit (microparticle enzyme-linked immunoassay)
Abbott Ireland Diagnostics Division
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
41
Into 11-0424
Free Triiodothyronine Assay Kit (Microparticle Enzyme Immunoassay)
Abbott Ireland Diagnostics Division
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
42
Into 11-0426
Ferritin assay kit (microparticle enzyme immunoassay)
Abbott Ireland Diagnostics Division
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
43
Into 11-0482
Theophylline II Standard Calibrator
Abbott Laboratories
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
44
Into 11-0635
Amylase test paper (dry chemical method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
45
Into 11-0637
Alanine aminotransferase test strip (dry chemical method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
46
Into 11-0645
Bilirubin test strip (dry chemical method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
47
Into 11-0647
Hemoglobin test strips (dry chemistry method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
48
Into 11-0648
Amylase test paper (dry chemical method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
49
Jin 11-0649
Transglutaminase test strips (dry chemistry method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
50
Into 11-0652
Creatinine test paper (dry chemical method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
51
Into 11-0653
Aspartate aminotransferase test strip (dry chemical method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
52
Into 11-0659
Cholesterol test paper (dry chemical method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
53
Into 11-0766
Electrolyte calibrator
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
54
Into 11-0154
Light chain detection kit (immunoturbidimetry)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
55
Into 10-1807
CD4 APC-Cy7 Detection Reagent (Flow Cytometry)
BD Biosciences
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
56
Into 10-2588
Myoglobin test quality control
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
57
Into 11-0658
Creatine kinase test strip (dry chemical method)
Roche Diagnostics GmbH
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.

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