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On May 16, the State Food and Drug Administration issued the "Announcement on Approval and Registration of 212 Medical Device Products (April 2022) (.
38 of 2022.
The announcement shows that in April 2022, the State Drug Administration approved a total of 212 registered medical device produc.
Among them, there are 154 domestic third-class medical device products, 35 imported third-class medical device products, 20 imported second-class medical device products, and 3 Hong Kong, Macao and Taiwan medical device produc.
The details are as follows: Serial number Product name Registrant name Registration certificate number Domestic third-class medical device 1 Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) Nanjing Shenji Pharmaceutical Technology .
, L.
National Machinery Note 20223400427 3 Novel coronavirus (2019-nCoV) IgM/IgG antibody detection kit (colloidal gold method) Hangzhou Laihe Biotechnology .
, L.
National Machinery Note 20223400428 4 Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold Method) Shandong Broke Diagnostic Technology .
, L.
National Machinery Note 20223400430 5 Magnetic Resonance Imaging System Xingaoyi Medical Equipment .
, L.
National Machinery Note 20223060431 6 Automatic nucleic acid extraction and purification and real-time fluorescent PCR analysis system Shanghai Zhijiang Biomedical Technology .
, L.
National Machinery Note 20223220432 7 Disposable anesthesia puncture needle Shanghai Mingzhou Medical Technology .
, L.
National Mechanical Note 20223080433
38 of 2022.
The announcement shows that in April 2022, the State Drug Administration approved a total of 212 registered medical device produc.
Among them, there are 154 domestic third-class medical device products, 35 imported third-class medical device products, 20 imported second-class medical device products, and 3 Hong Kong, Macao and Taiwan medical device produc.
The details are as follows: Serial number Product name Registrant name Registration certificate number Domestic third-class medical device 1 Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) Nanjing Shenji Pharmaceutical Technology .
, L.
National Machinery Note 20223400427 3 Novel coronavirus (2019-nCoV) IgM/IgG antibody detection kit (colloidal gold method) Hangzhou Laihe Biotechnology .
, L.
National Machinery Note 20223400428 4 Novel Coronavirus (2019-nCoV) Antigen Detection Kit (Colloidal Gold Method) Shandong Broke Diagnostic Technology .
, L.
National Machinery Note 20223400430 5 Magnetic Resonance Imaging System Xingaoyi Medical Equipment .
, L.
National Machinery Note 20223060431 6 Automatic nucleic acid extraction and purification and real-time fluorescent PCR analysis system Shanghai Zhijiang Biomedical Technology .
, L.
National Machinery Note 20223220432 7 Disposable anesthesia puncture needle Shanghai Mingzhou Medical Technology .
, L.
National Mechanical Note 20223080433
