BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PREGMATE Ovulation LH Test

    Reg #: 3013679502 · FEI: 3013679502 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PREGMATE LLC
    Registration Number
    3013679502
    FEI Number
    3013679502
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3804 N 29th Ave
    City
    Hollywood
    State
    FL
    ZIP
    33020
    Country
    US

    Regulatory Submissions

    510(k) Number
    K012252

    Owner / Operator

    Firm Name
    PREGMATE LLC
    Operator Number
    10055200
    Address
    2268 ANCHOR CT
    City
    Fort Lauderdale
    State
    FL
    Postal Code
    33312
    Country
    US
    Correspondent
    VIKTAR MAROZAU

    Products

    Device Name Product Code
    Radioimmunoassay, Luteinizing Hormone CEP

    Proprietary Names

    PREGMATE Ovulation LH Test PREGMATE Ovulation LH Midstream Test PREGMATE Ovulation LH Test Strip PREGMATE One Step Urine Ovulation LH Test

    Establishment Types

    Repack or Relabel Medical Device