BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    SpermFilter

    Reg #: 3036725842 · FEI: 3036725842 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GYNOTEC B.V.
    Registration Number
    3036725842
    FEI Number
    3036725842
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rijksweg 150
    City
    Malden Gelderland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K053494

    Owner / Operator

    Firm Name
    Gynotec B.V.
    Operator Number
    10092680
    Address
    Rijksweg 150
    City
    Malden
    State
    Gelderland
    Postal Code
    6581 ET
    Country
    NL
    Correspondent
    Marlou van Beek - Berbers

    US Agent

    Business Name
    Rook Quality Systems
    Contact Name
    Kyle Rose
    Address
    1155 Mount Vernon Hwy Ste 800
    City
    Dunwoody
    State
    GA
    ZIP
    30338
    Country
    US
    Email
    [email protected]
    Phone
    404 7179358

    Products

    Device Name Product Code
    Media, Reproductive MQL

    Proprietary Names

    SpermFilter SpermCryo All-round

    Establishment Types

    Repack or Relabel Medical Device