BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    TECHNOCLONE

    Reg #: 3003453957 · FEI: 3003453957 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    TECHNOCLONE
    Registration Number
    3003453957
    FEI Number
    3003453957
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Brunner Strase 67
    City
    Vienna Wien
    Country
    AT

    Regulatory Submissions

    510(k) Number
    DEN230024

    Owner / Operator

    Firm Name
    Technoclone Herstellung v. Diagnostika u. Arzneimitteln GmbH
    Operator Number
    10031758
    Address
    Brunner Str. 67
    City
    Vienna
    State
    Wien
    Postal Code
    1230
    Country
    AT
    Correspondent
    Veronika Binder

    US Agent

    Business Name
    Diapharma Group, Inc.
    Contact Name
    Jennifer Kiblinger
    Address
    8948 Beckett Rd
    City
    West Chester
    State
    OH
    ZIP
    45069
    Country
    US
    Email
    [email protected]
    Phone
    513 8609324 ext. 1723

    Products

    Device Name Product Code
    Detergent JCB
    Plasma, Coagulation Control GGN
    Calculator/Data Processing Module, For Clinical Use JQP
    Calibrator, Primary JIS
    Adamts13 Activity Test System SAC

    Proprietary Names

    DG Clean Technozym ADAMTS13 Activity

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device