BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SpermRinse

    Reg #: 3003274090 · FEI: 3003274090 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Vitrolife Inc.
    Registration Number
    3003274090
    FEI Number
    3003274090
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3601 South Inca Street
    City
    Englewood
    State
    CO
    ZIP
    80110
    Country
    US

    Regulatory Submissions

    510(k) Number
    K000621

    Owner / Operator

    Firm Name
    VITROLIFE AB
    Operator Number
    9037178
    Address
    Gustaf Werners gata 2
    City
    Vastra Frolunda
    State
    Vastra Gotaland
    Postal Code
    SE-421 32
    Country
    SE
    Correspondent
    NINA - ARVIDSSON

    Products

    Device Name Product Code
    Media, Reproductive MQL

    Proprietary Names

    SpermRinse

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)