BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Primus Hearing instrument test unit - PHITU

    Reg #: 3008386587 · FEI: 3008386587 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    Calibrator, Hearing Aid / Earphone And Analysis Systems ETW

    Proprietary Names

    Primus Hearing instrument test unit - PHITU OTOPro 2000 Primus HIT Pro 2005-1 HIT Unit HIT Unit Unity 3 HIT Unit

    Establishment Types

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