BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD.

    Reg #: 3016734135 · FEI: 3016734135 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    TAIWAN COMFORT CHAMP MANUFACTURING CO., LTD.
    Registration Number
    3016734135
    FEI Number
    3016734135
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No. 55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist.
    City
    Taoyuan City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K212863

    Owner / Operator

    Firm Name
    TAIWAN COMFORT CHAMP MANUFACTURING Co., LTD.
    Operator Number
    10068241
    Address
    No. 55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist.,
    City
    Taoyuan City
    State
    TW-TAO
    Postal Code
    330058
    Country
    TW
    Correspondent
    Ula Ho

    US Agent

    Business Name
    Promedic, LLC.
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr Ne
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076060

    Products

    Device Name Product Code
    Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua QKR
    Accessory, Surgical Apparel LYU
    Mask, Surgical FXX

    Proprietary Names

    Face Mask Uneed Pleated Activated Carbon Mask Uneed Pleated Mask Craftsman Flat-Fold Stretch Activated Carbon Mask Face Masks Taiwan Champ 3D Face Mask (Flexible) Uneed Flat-Fold Stretch Activated Carbon Mask Uneed Flat-Fold Stretch Mask Craftsman Pleated Mask Craftsman Flat-Fold Stretch Mask Craftsman Pleated Activated Carbon Mask Taiwan Champ Medical Face Mask Surgical Face Mask

    Establishment Types

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