BEUDAMED
    FDA Registration Active 🇫🇷 France

    BIOPHEN UFH Calibrator

    Reg #: 3004434070 · FEI: 3004434070 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    HYPHEN BIOMED SASU
    Registration Number
    3004434070
    FEI Number
    3004434070
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    155 RUE D ERAGNY
    City
    NEUVILLE SUR OISE Val-d'Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K051472

    Owner / Operator

    Firm Name
    HYPHEN BIOMED
    Operator Number
    9067801
    Address
    155 RUE D' ERAGNY, ZAC NEUVILLE - UNIVERSITE
    City
    NEUVILLE SUR OISE
    State
    FR-NOTA
    Postal Code
    95000
    Country
    FR

    US Agent

    Business Name
    ANIARA DIAGNOSTICA LLC
    Contact Name
    Michele Washing
    Address
    7768 SERVICE CENTER DR, WEST CHESTER
    City
    West Chester
    State
    OH
    ZIP
    45069
    Country
    US
    Email
    [email protected]
    Phone
    513 3422075

    Products

    Device Name Product Code
    Assay, Heparin KFF
    Plasma, Coagulation Control GGN
    Control, Plasma, Abnormal GGC

    Proprietary Names

    BIOPHEN UFH Calibrator BIOPHEN Heparin Calibrator BIOPHEN LMWH CONTROL LOW BIOPHEN LMWH CONTROL BIOPHEN LMWH CONTROL LOW CII-224401 BIOPHEN UFH CONTROL PLASMA-223101 BIOPHEN LMWH CONTROL C3-223801 BIOPHEN UFH CONTROL C1-224101 BIOPHEN LMWH CONTROL LOW CI-224301 BIOPHEN UFH CONTROL C2-223901 BIOPHEN LMWH CONTROL C4-224201

    Establishment Types

    Manufacture Medical Device