BEUDAMED
    FDA Registration Active 🇫🇷 France

    Fiber Force products (repackaged product of Fast Splint)

    Reg #: 3008757014 · FEI: 3008757014 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BIO COMPOSANTS MEDICAUX (BCM)
    Registration Number
    3008757014
    FEI Number
    3008757014
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    215 Route de Bavonne, ZA Le Talamud
    City
    SAINT BLAISE DU BUIS Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K102207

    Owner / Operator

    Firm Name
    BIO COMPOSANTS MEDICAUX (BCM)
    Operator Number
    10035008
    Address
    215 route de Bavonne
    City
    Saint Blaise Du Buis
    State
    Isere
    Postal Code
    38140
    Country
    FR
    Correspondent
    Leonie Biserta

    US Agent

    Business Name
    Synca Direct
    Contact Name
    Patrizia Manna
    Address
    1320 State Route #9
    City
    Champlain
    State
    NY
    ZIP
    12919
    Country
    US
    Email
    [email protected]
    Phone
    888 5828115

    Products

    Device Name Product Code
    Resin, Denture, Relining, Repairing, Rebasing EBI

    Proprietary Names

    Fiber Force products (repackaged product of Fast Splint)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device