BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    MedGem

    Reg #: 3009507357 · FEI: 3009507357 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WHOLECARE BIOMEDICAL CORPORATION
    Registration Number
    3009507357
    FEI Number
    3009507357
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8F, No. 443, Ruiguang Rd, Neihu Dist.
    City
    Taipei City
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K021605

    Owner / Operator

    Firm Name
    Wholecare Biomedical Corporation
    Operator Number
    10039146
    Address
    8F, No. 443, Ruiguang Rd, Neihu Dist.
    City
    Taipei City
    State
    TW-TPE
    Postal Code
    114
    Country
    TW

    US Agent

    Business Name
    mdi Consultants, Inc.
    Contact Name
    Alan Schwartz
    Address
    55 Northern Blvd
    City
    Great Neck
    State
    NY
    ZIP
    11021
    Country
    US
    Email
    [email protected]
    Phone
    516 4829001

    Products

    Device Name Product Code
    Computer, Oxygen-Uptake BZL

    Proprietary Names

    MedGem

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)