BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    2000 Primus fitting unit + - PFU+

    Reg #: 3008386587 · FEI: 3008386587 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    Auditdata A/S
    Registration Number
    3008386587
    FEI Number
    3008386587
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Wildersgade 10B
    City
    Copenhagen Hovedstaden
    Country
    DK

    Owner / Operator

    Firm Name
    Auditdata A/S
    Operator Number
    10032598
    Address
    Wildersgade 10B
    City
    Copenhagen
    State
    Hovedstaden
    Postal Code
    1408
    Country
    DK
    Correspondent
    Christian Holmelund

    US Agent

    Business Name
    Auditdata LLC
    Contact Name
    Christian Holmelund
    Address
    88 Glocker Way, #352
    City
    Pottstown
    State
    PA
    ZIP
    19465
    Country
    US
    Email
    [email protected]
    Phone
    610 7689300

    Products

    Device Name Product Code
    Audiometer EWO

    Proprietary Names

    2000 Primus fitting unit + - PFU+ Entomed SA 202 2000 Primus Ice Entomed SA 201 Entomed SA 203 Amplitude T-Series Entomed SA 204 2000 Primus fitting unit Pro - PFU Pro OTOSphere OTOPod 2000 Primus fitting unit - PFU 2000-1 FU - Measure Measure 2000-1 Fitting Unit 2000-1 FU - Unity 4 2000-1 Fitting Unit - Unity 4 2000-1 FU Unity 4 2000-1 Fitting Unit - Measure

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198