Acousticon Hörsysteme GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000013831
- Devices
- 5
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Acousticon Hörsysteme GmbH makes
Acousticon Hörsysteme GmbH manufactures audiological diagnostic equipment, including hardware components and software modules for hearing field analysis, in-situ testing, and audiometry. Their portfolio includes devices for measuring hearing thresholds, assessing sound field conditions, and evaluating hearing aid performance in real-world environments.
The company’s products are classified as Class IIa medical devices and are registered in the EU’s eudamed database. Acousticon Hörsysteme GmbH is based in Germany.
Catalogue
ACAM 5 Modul Hörfelddiagnose Ref A0102400
Regimes: CE MDR Registry: EUDAMEDACAM 5 Modul Insitu Ref A1025051
Regimes: CE MDR Registry: EUDAMEDACAM 5 Hardware Ref A1024536
Regimes: CE MDR Registry: EUDAMEDACAM 5 Modul Messbox Ref A0102401
Regimes: CE MDR Registry: EUDAMEDACAM 5 Modul Audiometer Ref A1025050
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- DE-MF-000013831
- EU VAT number
- DE 111612260
- EUDAMED status
- Active
- EUDAMED registered name
- Acousticon Hörsysteme GmbH
- Registered address
- 48, Hirschbachstraße, 64354, Reinheim, Germany
- Website
- www.acousticon.eu
- facebook.com/acousticon.gmbh
- [email protected]
- Phone
- +49 6162 93240
- PRRC contact
- Christopher Bonsel
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 23 Sep 2029
DNV MEDCERT GmbH 0482 1 certificate
- 1379GB449250929 Active
Quality assurance EU MDR
- Issued
- 29 Sep 2025
- Expires
- 23 Sep 2029
From the company website
New presentation of smartALF Our latest smartALF customization technique, an interactive customization technique with intuitive software operation and a guided customization process based on the loudness-based procedure Acousticon-LoudnessFitting (ALF), experienced a real run. The self-sufficient customization technology requires only a PC (or tablet) with Internet connection and can be used immediately – thanks to the associated free field headphone A2000 also outside the customization cabin. Since the operation is possible in both German and English and Spanish, smartALF was ordered not only by German hearing acoustics specialists, but also from different countries in Europe and the world. Production is ongoing and the first deliveries are already scheduled.
Frequently asked questions
How many devices does Acousticon Hörsysteme GmbH have in the registry?
The registry currently lists 5 devices for Acousticon Hörsysteme GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Acousticon Hörsysteme GmbH's devices?
Among its 5 most recently registered devices, Acousticon Hörsysteme GmbH has devices listed in EUDAMED (5 devices).
What risk classes do Acousticon Hörsysteme GmbH's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Acousticon Hörsysteme GmbH's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Acousticon Hörsysteme GmbH?
EUDAMED lists 1 certificate for Acousticon Hörsysteme GmbH (quality assurance) under MDR. 1 is recorded with the status issued. The most recent was issued on 29 Sep 2025.
What are the newest devices from Acousticon Hörsysteme GmbH in the registry?
The most recently registered devices listed for Acousticon Hörsysteme GmbH include ACAM 5 Modul Hörfelddiagnose, ACAM 5 Modul Insitu, ACAM 5 Hardware and ACAM 5 Modul Messbox.