BEUDAMED
    FDA Registration Active 🇧🇪 Belgium

    Fujirebio Europe N.V.

    Reg #: 9615837 · FEI: 3002608770 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    44
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    Fujirebio Europe N.V.
    Registration Number
    9615837
    FEI Number
    3002608770
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    TECHNOLOGIEPARK 6
    City
    GHENT Oost-Vlaanderen
    Country
    BE

    Regulatory Submissions

    510(k) Number
    K242706
    PMA Number
    P160016

    Owner / Operator

    Firm Name
    Fujirebio Diagnostics, Inc.
    Operator Number
    10022860
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    Greg Dickson

    US Agent

    Business Name
    Fujirebio Diagnostics, Inc.
    Contact Name
    Greg Dickson
    Address
    201 Great Valley Parkway
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US
    Email
    [email protected]
    Phone
    610 2403888

    Products

    Device Name Product Code
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Cytokeratin Fragments 21-1 Eia Kit OVK
    Assay, Genotyping, Hepatitis C Virus OBF
    Immunoassay Blood Test For Amyloid Pathology Assessment SET

    Proprietary Names

    Lumipulse B-Amyloid Plasma Controls Alinity i Methotrexate Controls (China) NSE [For use with] Alinity i Controls Atellica IM Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens Atellica IM Tumor Marker Quality Controls (TMQC) - Siemens Beckman PK-CMV PA Controls Lumipulse G BRAHMS PCT Controls Lumipulse ? Amyloid Controls Alinity i CYFRA 21-1 Controls (China) Alinity i Methotrexate Controls (ROW) Lumipulse pTau 217 Plasma Controls ARCHITECT Methotrexate Extended Range Controls (ROW) ARCHITECT CYFRA 21-1 Controls Alinity i Methotrexate Extended Range Controls (ROW) ARCHITECT CYFRA 21-1 Controls (China) NSE [For use with] Alinity i Controls (ROW) Alinity i CYFRA 21-1 Controls ADVIA Centaur XPT Tumor Marker Quality Controls (TMQC) - Siemens NSE [For use with] ARCHITECT Controls Alinity i CYFRA 21-1 Controls (ROW) ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens ARCHITECT Methotrexate Extended Range Controls (China) Alinity i Methotrexate Extended Range Controls (China) NSE [For us with] ARCHITECT Controls (ROW) ARCHITECT CYFRA 21-1 Controls (ROW) ARCHITECT Thyroglobulin Controls Alinity i Thyroglobulin Controls TENDIGO Cat No. 80412 TENDIGO Disposable Trays Cat no. 80421 ADVIA Centaur XPT Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL) - Siemens ADVIA Centaur XPT Cytokeratin Fragment 21-1 (CYFRA) - Siemens Atellica IM Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL) - Siemens Atellica IM Cytokeratin Fragment 21-1 (CYFRA) - Siemens INNO-LiPA HCV 2 Genotyping 40T, IVD-US INNO-LiPA HCV 2 Control 6T, IVD-US INNO-LiPA HCV 2 Amp 40T, IVD-US INNO-LiPA HCV 2 Amp 100T, IVD-US INNO-LiPA HCV 2 Genotyping 100T, IVD-US LiRAS for LiPA HCV v1 IVD-US Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Lumipulse G B-Amyloid 1-42-N Plasma IC Lumipulse G B-Amyloid 1-42-N Plasma Calibrators Lumipulse G pTau 217 Plasma Calibrators Lumipulse G pTau 217 Plasma IC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility