BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    GEM Biover Clamps

    Reg #: 3006947772 · FEI: 3006947772 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DIADEM CORPORATION
    Registration Number
    3006947772
    FEI Number
    3006947772
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    582-7, Ubaga-cho, Hitachiomiya-shi
    City
    Ibaraki
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K221843

    Owner / Operator

    Firm Name
    Wonderworks Inc.
    Operator Number
    10084536
    Address
    5-5-5, Takinogawa, Kita-Ku
    City
    Tokyo
    State
    JP-13
    Postal Code
    114-0023
    Country
    JP
    Correspondent
    Maha Nolasco

    US Agent

    Business Name
    Baxter Healthcare Corporation
    Contact Name
    Maha Nolasco
    Address
    25212 W. IL Route 120, RLT-04
    City
    Round Lake
    State
    IL
    ZIP
    60073
    Country
    US
    Email
    [email protected]
    Phone
    224 2706181

    Products

    Device Name Product Code
    Clamp, Vascular DXC

    Proprietary Names

    GEM Biover Clamps

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)