BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ORGENTEC DIAGNOSTIKA GMBH

    Reg #: 3003232042 · FEI: 3003232042 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORGENTEC DIAGNOSTIKA GMBH
    Registration Number
    3003232042
    FEI Number
    3003232042
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CARL-ZEISS-STRASSE 49-51
    City
    MAINZ Rhineland-Palatinate
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K092399

    Owner / Operator

    Firm Name
    Corgenix Inc.
    Operator Number
    9022938
    Address
    11575 Main St, Suite 400
    City
    Broomfield
    State
    CO
    Postal Code
    80020
    Country
    US

    US Agent

    Business Name
    Corgenix Inc
    Contact Name
    Souda Truong
    Address
    11575 Main St Unit 400
    City
    Broomfield
    State
    CO
    ZIP
    80020
    Country
    US
    Email
    [email protected]
    Phone
    303 4574345 ext. 130

    Products

    Device Name Product Code
    Anti-Mutated Citrullinated Vimentin Igg OQZ

    Establishment Types

    Manufacture Medical Device