BEUDAMED
    FDA Registration Active 🇫🇷 France

    Hemoglobin Capillary Collection System

    Reg #: 3035708936 · FEI: 3035708936 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Bio-Rad Service France SAS
    Registration Number
    3035708936
    FEI Number
    3035708936
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rue des Freres Lumiere
    City
    Mitry Mory Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K090737

    Owner / Operator

    Firm Name
    Bio-Rad Laboratories (Bio-Rad Services France)
    Operator Number
    10078397
    Address
    Rue Gustave Eiffel
    City
    MITRY-MORY
    State
    Ile-de-France
    Postal Code
    77290
    Country
    FR
    Correspondent
    Lucie Watremetz

    US Agent

    Business Name
    BIO-RAD LABORATORIES
    Contact Name
    David Bhend
    Address
    14620 Ne North Woodinville Way
    City
    Woodinville
    State
    WA
    ZIP
    98072
    Country
    US
    Email
    [email protected]
    Phone
    425 2730193

    Products

    Device Name Product Code
    Assay, Glycosylated Hemoglobin LCP
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA

    Proprietary Names

    Hemoglobin Capillary Collection System

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device