BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    MOTILITYCOUNT APS

    Reg #: 3015550658 · FEI: 3015550658 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    MOTILITYCOUNT APS
    Registration Number
    3015550658
    FEI Number
    3015550658
    Status
    Active
    Expiry Year
    2026
    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
    Labware, Assisted Reproduction MQK

    Proprietary Names

    SwimCount Sperm Quality Test SwimCount® Harvester

    Establishment Types

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