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    Home > Medical News > Latest Medical News > The State Food and Drug Administration cancels the medical device registration certificate of Tianzhihang Medical and other enterprises

    The State Food and Drug Administration cancels the medical device registration certificate of Tianzhihang Medical and other enterprises

    • Last Update: 2022-08-15
    • Source: Internet
    • Author: User
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    On May 10, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", according to the application of enterprises, the State Food and Drug Administration cancelled the registration certificates of medical devices for 6 products below 3 companies including Shenzhen Boka Biotechnology .
    ,L.
     
    Four products of Shenzhen Boka Biotechnology .
    , L.
    : Cytomegalovirus (CMV) IgM antibody detection kit (enzyme-linked immunosorbent assay) Ⅱ) IgM antibody detection kit (enzyme-linked immunosorbent assay), registration number: National Machinery Note 20173400930; Toxoplasma (Tox) IgM antibody detection kit (enzyme-linked immunosorbent assay), registration number: National Machinery Note 20173400932 ; Rubella virus (RV) IgM antibody detection kit (enzyme-linked immunosorbent assay), registration number: National Machinery Note 2017340093
     
    One product of Beijing Tianzhihang Medical Technology .
    , L.
    : Orthopedic surgery navigation system, registration certificate number: National Machinery Note 2019301189
     
    1 product of ELECTRONIC CONCEPT LIGNON INNOVATION: Neuromuscular Stimulation Therapy Apparatus, registration number: National Machinery Injection 2017221196
    On May 10, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", according to the application of enterprises, the State Food and Drug Administration cancelled the registration certificates of medical devices for 6 products below 3 companies including Shenzhen Boka Biotechnology .
    ,L.
     
    Four products of Shenzhen Boka Biotechnology .
    , L.
    : Cytomegalovirus (CMV) IgM antibody detection kit (enzyme-linked immunosorbent assay) Ⅱ) IgM antibody detection kit (enzyme-linked immunosorbent assay), registration number: National Machinery Note 20173400930; Toxoplasma (Tox) IgM antibody detection kit (enzyme-linked immunosorbent assay), registration number: National Machinery Note 20173400932 ; Rubella virus (RV) IgM antibody detection kit (enzyme-linked immunosorbent assay), registration number: National Machinery Note 2017340093
     
    One product of Beijing Tianzhihang Medical Technology .
    , L.
    : Orthopedic surgery navigation system, registration certificate number: National Machinery Note 2019301189
     
    1 product of ELECTRONIC CONCEPT LIGNON INNOVATION: Neuromuscular Stimulation Therapy Apparatus, registration number: National Machinery Injection 2017221196
    On May 10, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", according to the application of enterprises, the State Food and Drug Administration cancelled the registration certificates of medical devices for 6 products below 3 companies including Shenzhen Boka Biotechnology .
    ,L.
     
    Four products of Shenzhen Boka Biotechnology .
    , L.
    : Cytomegalovirus (CMV) IgM antibody detection kit (enzyme-linked immunosorbent assay) Ⅱ) IgM antibody detection kit (enzyme-linked immunosorbent assay), registration number: National Machinery Note 20173400930; Toxoplasma (Tox) IgM antibody detection kit (enzyme-linked immunosorbent assay), registration number: National Machinery Note 20173400932 ; Rubella virus (RV) IgM antibody detection kit (enzyme-linked immunosorbent assay), registration number: National Machinery Note 2017340093
     
    One product of Beijing Tianzhihang Medical Technology .

    , L.

    : Orthopedic surgery navigation system, registration certificate number: National Machinery Note 2019301189
     
    1 product of ELECTRONIC CONCEPT LIGNON INNOVATION: Neuromuscular Stimulation Therapy Apparatus, registration number: National Machinery Injection 2017221196
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