BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    BIOCARTIS NV

    Reg #: 3009972873 · FEI: 3009972873 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    5
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    BIOCARTIS NV
    Registration Number
    3009972873
    FEI Number
    3009972873
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Generaal De Wittelaan 11B
    City
    Mechelen Antwerpen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K211181
    PMA Number
    P250005

    Owner / Operator

    Firm Name
    Biocartis NV
    Operator Number
    10055159
    Address
    Generaal De Wittelaan 11B
    City
    Mechelen
    State
    Antwerpen
    Postal Code
    2800
    Country
    BE
    Correspondent
    Benjamin Crystal

    US Agent

    Business Name
    Biocartis US, Inc
    Contact Name
    Benjamin Crystal
    Address
    2 Pierce Pl Ste 1510
    City
    Itasca
    State
    IL
    ZIP
    60143
    Country
    US
    Email
    [email protected]
    Phone
    508 8432809

    Products

    Device Name Product Code
    Nucleic Acid Based Assay, Microsatellite Instability SFL
    Real Time Nucleic Acid Amplification System OOI
    Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers PRE
    Lynch Syndrome Test System PZJ

    Proprietary Names

    Idylla™ CDx MSI Test Idylla™ System (Idylla™ Instrument and Idylla™ Hub) Idylla™ System (Idylla™ Console and Idylla™ Instrument) SeptiCyte RAPID Idylla MSI Test

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)