BEUDAMED
    FDA Registration Active 🇫🇷 France

    CAPILLARYS HB A1C USING CAPILLARYS 2 FLEX PIERCING

    Reg #: 8023024 · FEI: 6387 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SEBIA
    Registration Number
    8023024
    FEI Number
    6387
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PARC TECHNOLOGIQUE LEONARD DE VINCI
    City
    EVRY Essonne
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K171861

    Owner / Operator

    Firm Name
    SEBIA
    Operator Number
    8023024
    Address
    PARC TECHNOLOGIQUE LEONARD DE, 27 rue Leonard de VINCI
    City
    Lisses-Evry
    State
    FR-NOTA
    Postal Code
    91008
    Country
    FR
    Correspondent
    Arnaud - Collin

    US Agent

    Business Name
    Sebia
    Contact Name
    Karen A Anderson
    Address
    1705 Corporate Drive, Suite 400
    City
    Norcross
    State
    GA
    ZIP
    30093
    Country
    US
    Email
    [email protected]
    Phone
    404 7881059

    Products

    Device Name Product Code
    Hemoglobin A1c Test System PDJ

    Proprietary Names

    CAPILLARYS HB A1C USING CAPILLARYS 2 FLEX PIERCING

    Establishment Types

    Manufacture Medical Device