BEUDAMED
    FDA Registration Active 🇨🇳 China

    BIOHIT HEALTHCARE (HEFEI) CO., LTD.

    Reg #: 3016850770 · FEI: 3016850770 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    4

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    Registration Details

    Registration Name
    BIOHIT HEALTHCARE (HEFEI) CO., LTD.
    Registration Number
    3016850770
    FEI Number
    3016850770
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Biouhan Bio-Industrial Park, Northeast Corner, Intersection of Kongquetai Road and Chang'an Road, High-tech Zone
    City
    Hefei Anhui
    Country
    CN

    Owner / Operator

    Firm Name
    Biohit Healthcare (Hefei) Co., Ltd.
    Operator Number
    10069805
    Address
    Biouhan Bio-Industrial Park, Northeast Corner, Intersection of Kongquetai Road and Chang'an Road, High-tech Zone
    City
    Hefei
    State
    Anhui
    Postal Code
    230000
    Country
    CN
    Correspondent
    Linda Wang

    US Agent

    Business Name
    Willow Glen Consultancy LLC
    Contact Name
    Wen Wang
    Address
    8880 Rio San Diego Drive, #800
    City
    San Diego
    State
    CA
    ZIP
    92108
    Country
    US
    Email
    [email protected]
    Phone
    619 8690249

    Products

    Device Name Product Code
    Covid-19 Multi-Analyte Antigen Device QMN
    Coronavirus Antigen Detection Test System. QKP
    Multi-Analyte Respiratory Virus Antigen Detection Test SCA
    Reagent, Coronavirus Serological QKO

    Proprietary Names

    iHealth COVID-19/Flu A&B Rapid Test ( Model no. ICF-3000) iHealth Flu A&B/COVID-19/RSV Rapid Test (model: ICR-3000) SARS-CoV-2 IgM/IgG Antibody Test kit (Colloidal Gold Method) iHealth Flu A&B/COVID-19 Rapid Test (model: ICF-7000)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device