BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Auditdata A/S

    Reg #: 3008386587 · FEI: 3008386587 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    43
    Establishment Types
    4
    Classifications
    4

    Registration Details

    Registration Name
    Auditdata A/S
    Registration Number
    3008386587
    FEI Number
    3008386587
    Status
    Active
    Expiry Year
    2026
    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
    Cushion, Earphone (For Audiometric Testing) ETT
    Audiometer EWO
    Otoscope ERA

    Proprietary Names

    Primus Hearing instrument test unit - PHITU OTOPro 2000 Primus HIT Pro HIT Unit 2005-1 HIT Unit Measure by Otometrics - HIT Unity 3 HIT Unit HIT - Measure by Otometrics 3000 Real Ear 3000 Real Ear - IN1 IN1 Insert Earphone 2000-1 Fitting Unit - Measure by Otometrics 3000 Real Ear - CA1 CA1 HF Audiometric Headphone 3000 Real Ear - SA1 Entomed SA 203 Entomed SA 201 2000 Primus Ice Entomed SA 204 2000 Primus fitting unit + - PFU+ Entomed SA 202 OTOSphere OTOPod 2000 Primus fitting unit Pro - PFU Pro Amplitude T-Series 2000 Primus fitting unit - PFU Unity 4 2000-1 FU - Unity 4 Measure 2000-1 FU - Measure by Otometrics 2000-1 FU - Measure 2000-1 Fitting Unit SA1 HB-7 Headphone 2000-1 Fitting Unit - Unity 4 SA1 HBA Headphone SA1 RE-7 Headphone 2000-1 Fitting Unit - Measure 2000-1 FU CA1 Audiometric Headphone BC1 Bone Conductor 3000 Real Ear - BC1 Measure by Otometrics 2001 Primus Video Otoscope - PVO

    Establishment Types

    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 Develop Specifications But Do Not Manufacture At This Facility