BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Miltenyi Biotec B. V. & Co. KG

    Reg #: 3005290010 · FEI: 3004112148 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Miltenyi Biotec B. V. & Co. KG
    Registration Number
    3005290010
    FEI Number
    3004112148
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Friedrich-Ebert-Strasse 68
    City
    Bergisch Gladbach North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    BK090020

    Owner / Operator

    Firm Name
    Miltenyi Biotec/Dinsmore
    Operator Number
    10031807
    Address
    1 1st Ave., Bldg 34, Suite 401
    City
    Charlestown
    State
    MA
    Postal Code
    02129
    Country
    US
    Correspondent
    Jonathan Dinsmore

    US Agent

    Business Name
    Miltenyi Biotec
    Contact Name
    Jonathan Dinsmore
    Address
    1 1st Avenue, Building 34, STE 401
    City
    Boston
    State
    MA
    ZIP
    02129
    Country
    US
    Email
    [email protected]
    Phone
    617 4488043

    Products

    Device Name Product Code
    Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml) OVG
    Reagents, Specific, Analyte MVU
    Container, Frozen Donor Tissue Storage LPZ

    Proprietary Names

    CD34 Separation System ASR antibodies Freezing bags

    Establishment Types

    Manufacture Medical Device