BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    SwimCount Sperm Quality Test

    Reg #: 3015550658 · FEI: 3015550658 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MOTILITYCOUNT APS
    Registration Number
    3015550658
    FEI Number
    3015550658
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Gl. Koege Landevej 57 2
    City
    Valby Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K183602

    Owner / Operator

    Firm Name
    MotilityCount ApS
    Operator Number
    10061002
    Address
    Gl. Koege Landevej 57
    City
    Valby
    State
    Hovedstaden
    Postal Code
    DK-2500
    Country
    DK

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Semen Analysis Device POV

    Proprietary Names

    SwimCount Sperm Quality Test

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device