BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    ASTM PB70 Level 4 Isolation Gown

    Reg #: 3017276117 · FEI: 3017276117 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    MEDTECS (TAIWAN) CORP.
    Registration Number
    3017276117
    FEI Number
    3017276117
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11F, No. 9, Songgao Road, Xinyi Dist.
    City
    Taipei City
    Country
    TW

    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