BEUDAMED
    FDA Registration Active 🇫🇷 France

    bibag

    Reg #: 9616277 · FEI: 3003244997 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    S.M.A.D.
    Registration Number
    9616277
    FEI Number
    3003244997
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Z.I. DE LA PONCHONNIERE, ROUTE DE LA CHANADE
    City
    L'ARBRESLE Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K162716

    Owner / Operator

    Firm Name
    FRESENIUS MEDICAL CARE
    Operator Number
    8010838
    Address
    ELSE KROENER-STRASSE 1, --
    City
    BAD HOMBURG
    State
    Hesse
    Postal Code
    D-61352
    Country
    DE

    US Agent

    Business Name
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Contact Name
    DENISE OPPERMANN
    Address
    920 Winter St
    City
    North Waltham
    State
    MA
    ZIP
    02451
    Country
    US
    Email
    [email protected]
    Phone
    781 6994479 ext. 0

    Products

    Device Name Product Code
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO

    Proprietary Names

    bibag

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)