BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    IH-Card Control

    Reg #: 9610824 · FEI: 3002806595 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIO-RAD MEDICAL DIAGNOSTICS GMBH
    Registration Number
    9610824
    FEI Number
    3002806595
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    INDUSTRIESTR. 1
    City
    DREIEICH Hesse
    Country
    DE

    Regulatory Submissions

    510(k) Number
    BK140139

    Owner / Operator

    Firm Name
    Bio-Rad Medical Diagnostics GmbH
    Operator Number
    10032616
    Address
    Industriestrasse 1
    City
    Dreieich
    State
    Hesse
    Postal Code
    63303
    Country
    DE
    Correspondent
    Marc Gorzellik, PH.D.

    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
    Kit, Quality Control For Blood Banking Reagents KSF

    Proprietary Names

    IH-Card Control

    Establishment Types

    Manufacture Medical Device