BEUDAMED
    FDA Registration Active 🇨🇳 China

    COPIOUMED INTERNATIONAL, INC.

    Reg #: 9681151 · FEI: 3003792528 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    COPIOUMED INTERNATIONAL, INC.
    Registration Number
    9681151
    FEI Number
    3003792528
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    16F-4, No.1, Fuxing North Road, Songshan District
    City
    TAIPEI Taiwan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K002340

    Owner / Operator

    Firm Name
    COPIOUMED INTL., INC.
    Operator Number
    9019875
    Address
    16F-4, No.1, Fuxing North Road, Songshan District
    City
    TAIPEI
    State
    TW-TPE
    Postal Code
    105
    Country
    TW

    Products

    Device Name Product Code
    Vinyl Patient Examination Glove LYZ
    Accessory, Surgical Apparel LYU
    Polymer Patient Examination Glove LZA
    Suit, Surgical FXO
    Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs QSO
    Gown, Isolation, Surgical FYC
    Gown, Surgical FYA
    Shoe And Shoe Cover, Conductive BWP
    Cover, Shoe, Operating-Room FXP
    Cap, Surgical FYF
    Non-Surgical Gown OEA
    Garment, Protective, For Incontinence EYQ
    Mask, Surgical FXX
    Gown, Examination FME

    Proprietary Names

    MULTIPLE LABELS Copioumed Chemotherapy Isolation Gown GENERIC generic

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device