BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Primus Hearing instrument test unit - PHITU

    Reg #: 3004052117 · FEI: 3004052117 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Auditdata, LLC
    Registration Number
    3004052117
    FEI Number
    3004052117
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    88 Glocker Way, #352
    City
    Pottstown
    State
    PA
    ZIP
    19465
    Country
    US

    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

    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

    Complaint File Establishment per 21 CFR 820.198