BEUDAMED
    FDA Registration Active 🇧🇲 Bermuda

    ASTM PB70 Level 4 Isolation Gown

    Reg #: 3017171460 · FEI: 3017171460 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDTECS INTERNATIONAL CORPORATION LIMITED
    Registration Number
    3017171460
    FEI Number
    3017171460
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Clarendon House, 2 Church Street
    City
    City of Hamilton
    Country
    BM

    Regulatory Submissions

    510(k) Number
    K210414

    Owner / Operator

    Firm Name
    Medtecs (Taiwan) Corp.
    Operator Number
    10074525
    Address
    11F., No. 9, Songgao Road, Xinyi Dist.
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    11073
    Country
    TW

    Products

    Device Name Product Code
    Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs QSO
    Gown, Isolation, Surgical FYC

    Proprietary Names

    ASTM PB70 Level 4 Isolation Gown

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device