BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GM501 SpermAir

    Reg #: 3030390242 · FEI: 3030390242 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GYNEMED GMBH & CO. KG
    Registration Number
    3030390242
    FEI Number
    3030390242
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Wagrienring 24b
    City
    Sierksdorf Schleswig-Holstein
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K192644

    Owner / Operator

    Firm Name
    GYNEMED GmbH & Co. KG
    Operator Number
    10091740
    Address
    Wagrienring 24b
    City
    Sierksdorf
    State
    Schleswig-Holstein
    Postal Code
    23730
    Country
    DE
    Correspondent
    Dr. Julia Heinzmann

    US Agent

    Business Name
    Hamilton Thorne, Inc.
    Contact Name
    Nicole Thibodeau
    Address
    100 Cummings Ctr Ste 465e
    City
    Beverly
    State
    MA
    ZIP
    01915
    Country
    US
    Email
    [email protected]
    Phone
    978 9212050

    Products

    Device Name Product Code
    Media, Reproductive MQL

    Proprietary Names

    GM501 SpermAir GM501 SpermActive

    Establishment Types

    Manufacture Medical Device