Notice of Release of Production Approvals on June 17, 2011

No.
Acceptance number
Variety name
applicant
Note
1
10-0773
Medical digital X-ray photography system
Shanghai Medical Instrument Factory Co., Ltd.
2
Standard 10-1147
Glycyl Proline Dipeptide Aminopeptidase (GPDA) Assay Kit (Glycyl Proline vs Nitroaniline)
Changchun Huili Biotechnology Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
3
Standard 10-1148
L-Fucosidase (AFU) Assay Reagent (CPNP-Fucoside Rate Method)
Changchun Huili Biotechnology Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
4
Standard 10-1176
Ultrasound Color Doppler Scanner
5
Standard 10-1415
Magnetic resonance imaging system
Jiangsu Meishi Medical Technology Co., Ltd.
6
Standard 10-1495
Multi-leaf collimator
Shandong Xinhua Medical Devices Co., Ltd.
7
Standard 10-1501
Human immunodeficiency virus antibody test kit (colloidal gold method)
Xiamen Bosheng Biotechnology Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
8
Standard 10-1518
Hepatitis B virus surface antibody detection reagent (colloidal gold method)
Guangzhou Wanfu Biotechnology Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
9
Standard 11-0302
Hepatitis B virus surface antibody quantitative detection kit (chemiluminescence method)
Zhengzhou Antu Green Branch Biological Engineering Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.
10
Standard 11-0304
Hepatitis B virus core antibody diagnostic kit (chemiluminescence)
Zhengzhou Antu Green Branch Biological Engineering Co., Ltd.
In order to obtain a new medical device registration certificate, the original medical device registration certificate must be submitted.

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