BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Destiny MAX Analyzer

    Reg #: 3003943960 · FEI: 3003943960 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TCOAG DEUTSCHLAND GMBH
    Registration Number
    3003943960
    FEI Number
    3003943960
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LEHBRINKSWEG 59,
    City
    LEMGO North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K083896

    Owner / Operator

    Firm Name
    Tcoag Deutschland GmbH
    Operator Number
    10032697
    Address
    Lehbrinkweg 59, 32657, Lemgo
    City
    Lemgo
    State
    North Rhine-Westphalia
    Postal Code
    32657
    Country
    DE

    US Agent

    Business Name
    Diagnostica Stago, Inc
    Contact Name
    Donald Kraft
    Address
    5 Century Dr, New Jersey
    City
    Parsippany
    State
    NJ
    ZIP
    07054
    Country
    US
    Email
    [email protected]
    Phone
    973 6311200 ext. 4104

    Products

    Device Name Product Code
    System, Multipurpose For In Vitro Coagulation Studies JPA

    Proprietary Names

    Destiny MAX Analyzer

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)