BEUDAMED
    FDA Registration Active 🇫🇷 France

    HYPHEN BIOMED SASU

    Reg #: 3004434070 · FEI: 3004434070 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    10

    Registration Details

    Registration Name
    HYPHEN BIOMED SASU
    Registration Number
    3004434070
    FEI Number
    3004434070
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    155 RUE D ERAGNY
    City
    NEUVILLE SUR OISE Val-d'Oise
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K050365

    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, Inc.
    Contact Name
    Michele Washing
    Address
    7768 Service Center Dr
    City
    West Chester
    State
    OH
    ZIP
    45069
    Country
    US
    Email
    [email protected]
    Phone
    513 3422075

    Products

    Device Name Product Code
    Ph Buffer JCC
    Test, Qualitative And Quantitative Factor Deficiency GGP
    Assay, Heparin KFF
    Calibrator, Secondary JIT
    Plasma, Coagulation Control GGN
    Test, Time, Partial Thromboplastin GGW
    Antithrombin Iii Quantitation JBQ
    Control, Plasma, Abnormal GGC
    General Purpose Reagent PPM
    Platelet Factor 4 Radioimmunoassay LCO

    Proprietary Names

    AR021L Imidazole buffer 12x25 ml AR021K Imidazole buffer 3x25 ml AR021M Imidazole buffer 3x15ml AR021N Imidazole buffer 12x15ml AR021B Imidazole buffer 1x15ml BIOPHEN PROTEIN C5 BIOPHEN PROTEIN C 2.5 BIOPHEN HEPARIN 3 BIOPHEN HEPARIN 6 Biophen ACT PC-r Ctl Plasma(223405) Biophen VL Cal Undiluted (222401) Hemoclot Quanti V-L (CK065K) Biophen Normal Ctrl Plasma (223201) BIOPHEN ANTITHROMBIN 2.5 BIOPHEN ANTITROMBIN 5 BIOPHEN Heparin Calibrator BIOPHEN LMWH CONTROL LOW BIOPHEN UFH Calibrator BIOPHEN LMWH CONTROL BIOPHEN LMWH CONTROL C3-223801 BIOPHEN UFH CONTROL PLASMA-223101 BIOPHEN UFH CONTROL C2-223901 BIOPHEN LMWH CONTROL LOW CI-224301 BIOPHEN LMWH CONTROL C4-224201 BIOPHEN LMWH CONTROL LOW CII-224401 BIOPHEN UFH CONTROL C1-224101 AR001K Calcium chloride 0,025M (M/40) Set of 12x25 ml AR001B Calcium Chloride 025M (M/40) 3X15ml AR001L Calcium Chloride 025M (M/40) 12x15ml ZYMUTEST HIA MONOSTRIP IGGAM-RK041D ZYMUTEST HIA IGGAM-RK040D ZYMUTEST HIA IGG- RK040A ZYMUTEST HIA MONOSTRIP IGG-RK041A ZYMUTEST HIA IGG AND Z BIOPHEN PLASMA CALIBRATOR BIOPHEN NORMAL PLASMA BIOPHEN ABNORMAL PLASMA

    Establishment Types

    Manufacture Medical Device