BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Dextramer® CMV Kit

    Reg #: 3008096179 · FEI: 3008096179 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Immudex, Aps
    Registration Number
    3008096179
    FEI Number
    3008096179
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Bredevej 2A
    City
    Virum Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K153538

    Owner / Operator

    Firm Name
    Immudex
    Operator Number
    10033288
    Address
    Bredevej 2A
    City
    Virum
    State
    Hovedstaden
    Postal Code
    2830
    Country
    DK
    Correspondent
    Liselotte Brix

    US Agent

    Business Name
    IMMUDEX USA, LLC
    Contact Name
    Alessandra Audia
    Address
    10615 Judicial Dr Ste 402
    City
    Fairfax
    State
    VA
    ZIP
    22030
    Country
    US
    Email
    [email protected]
    Phone
    713 7057161

    Products

    Device Name Product Code
    Counter, Differential Cell GKZ

    Proprietary Names

    Dextramer® CMV Kit

    Establishment Types

    Manufacture Medical Device