Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008386587

FEI Number

3008386587

Entity Name

Auditdata A/S

City/State/Country

Copenhagen Hovedstaden, DK

Establishment Address

Wildersgade 10B, Copenhagen Hovedstaden 1408, DK

Establishment Type(s)

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,Foreign Private Label Distributor

Owner / Operator

Auditdata A/S (Owner Number: 10032598)

Owner / Operator Contact Address

Wildersgade 10B, Copenhagen, DK-84 1408, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 IN1 Insert Earphone CA1 Audiometric Headphone BC1 Bone Conductor 3000 Real Ear - IN1 3000 Real Ear 3000 Real Ear - BC1 Measure by Otometrics

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	Class 2	874.3310	2014-12-09
ETT	Cushion, Earphone (For Audiometric Testing)	Ear, Nose, Throat	Class 1	874.1100	2025-12-21
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2010-05-28

Official Correspondent

Christian Holmelund

US Agent Details

Christian Holmelund Business: Auditdata LLC Email: compliance@auditdata.com Phone: (610) 7689300

Related Public Records

Same Entity

Auditdata A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004052117	Auditdata, LLC	Pottstown, PA, US
3013596041	Inission Syd AB (Malmo AB)	Malmo Skane, SE
3030089857	Nordes Sp. z o.o.	Wroclaw Dolnoslaskie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

Similar Registrations

Registration Number	Establishment Name	Location
8022229	ETYMONIC DESIGN, INC.	DORCHESTER Ontario, CA
3011310592	DGS Diagnostics Sp. z o.o	Kolbaskowo Zachodniopomorskie, PL
3005019184	Sivantos GmbH	Erlangen Bavaria, DE
9612197	Natus Medical Denmark ApS	TAASTRUP Hovedstaden, DK
3030089857	Nordes Sp. z o.o.	Wroclaw Dolnoslaskie, PL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008386587. Last updated year: 2026. Please use registration number 3008386587 when referencing this establishment in official correspondence.