BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    ComfortTemp

    Reg #: 8022590 · FEI: 3495 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CAREMED SUPPLY, INC.
    Registration Number
    8022590
    FEI Number
    3495
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7F., NO.2, LANE 235, BAO CHIAO RD., XIN TIEN DIST.
    City
    NEW TAIPEI CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K231211

    Owner / Operator

    Firm Name
    Caremed Supply, Inc.
    Operator Number
    9102439
    Address
    7F., NO.2, LANE 235, BAO CHIAO RD., XIN TIEN DIST.
    City
    NEW TAIPEI CITY
    State
    TW-NOTA
    Postal Code
    23145
    Country
    TW

    US Agent

    Business Name
    Prius Healthcare USA, LLC
    Contact Name
    Richard Sorrento
    Address
    160 Scarlet Blvd
    City
    Oldsmar
    State
    FL
    ZIP
    34677
    Country
    US
    Email
    [email protected]
    Phone
    727 6424361

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ

    Proprietary Names

    ComfortTemp

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)