BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    FERTIPRO N.V.

    Reg #: 3003272500 · FEI: 3003272500 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    FERTIPRO N.V.
    Registration Number
    3003272500
    FEI Number
    3003272500
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    INDUSTRIE PARK NOORD 32
    City
    BEERNEM West-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K242640

    Owner / Operator

    Firm Name
    FERTIPRO N.V.
    Operator Number
    9046065
    Address
    INDUSTRIE PARK NOORD 32, BEERNEM
    City
    WEST-VLAANDEREN
    State
    BE-NOTA
    Postal Code
    8730
    Country
    BE
    Correspondent
    Liesbeth Faes

    US Agent

    Business Name
    Rook Quality Systems
    Contact Name
    Tyler Ting
    Address
    1155 Mount Vernon Hwy Ste 800
    City
    Dunwoody
    State
    GA
    ZIP
    30338
    Country
    US
    Email
    [email protected]
    Phone
    770 8330116

    Products

    Device Name Product Code
    Reagent, Immunoassay, Igg KTO
    Media, Reproductive MQL
    General Purpose Reagent PPM
    Microbial Nucleic Acid Storage And Stabilization Device QBD
    Stains, Chemical Solution LED
    Media, Reproductive, Exempt QKI

    Proprietary Names

    SpermMar Test IgG Complete kit – 50 tests SpermMar Test IgG – Negative control SpermMar Test IgG Single kit – 50 tests SpermMar Test IgA Complete kit – 50 tests SpermMar Test IgA Single kit – 50 tests SpermMar Test IgG – Positive control Assisted Reproduction Media HOS Test Media, Reproductive InActiv Blue VitalScreen Spermac Stain LeucoScreen Plus Media Reproductive Exempt

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)