BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    LACAR MDX TECHNOLOGIES

    Reg #: 3042250641 · FEI: 3042250641 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    4
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    LACAR MDX TECHNOLOGIES
    Registration Number
    3042250641
    FEI Number
    3042250641
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Rue des Chasseurs Ardennais 10
    City
    Liege
    Country
    BE

    Regulatory Submissions

    510(k) Number
    DEN150035

    Owner / Operator

    Firm Name
    LaCAR MDx Technologies
    Operator Number
    10094131
    Address
    Rue des Chasseurs Ardennais 10
    City
    Liège
    State
    Liege
    Postal Code
    4031
    Country
    BE
    Correspondent
    Arnaud Allaer

    Products

    Device Name Product Code
    Alpha-D-Galactosidase A (Gla) Newborn Screening Test System PQW
    Alpha-L-Iduronidase (Idua) Newborn Screening Test System PQT
    ß-Glucocerebrosidase (Gba) Newborn Screening Test System PQV
    Alpha-D-Glucosidase (Gaa) Newborn Screening Test System PQU
    Reagents, Specific, Analyte MVU
    Fluorometer, For Clinical Use KHO
    General Purpose Reagent PPM

    Proprietary Names

    SEEKER Analyte Specific Reagent SEEKER Instrument General Purpose Reagent

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility