Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013596041

FEI Number

3013596041

Entity Name

Inission Syd AB (Malmo AB)

City/State/Country

Malmo Skane, SE

Establishment Address

Jaegersrovaegen 204, Malmo Skane 21377, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

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
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
3008386587	Auditdata A/S	Copenhagen Hovedstaden, DK
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
2011951	AMBCO ELECTRONICS, A CALIFORNIA CORP.	TUSTIN, CA, US
3013333417	HEAR.COM LLC (TELE-DX)	Coral Gables, FL, US
3013598036	WAHTS Hearing LLC	West Lebanon, NH, US
2113281	DIAGNOSTIC GROUP LLC	EDEN PRAIRIE, MN, US
3043496923	EARGYM LTD	London London, City of, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013596041. Last updated year: 2026. Please use registration number 3013596041 when referencing this establishment in official correspondence.