Instruments for functional explorations and therapeutic interventionsGeneral medicine instrumentsGeneral medicine therapeutic treatment instruments
General medicine therapeutic treatment instruments - software accessories
EMDN code Z12040282
Manufacturers registered in Europe (EUDAMED) 17
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 31
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Cochlear Bone Anchored Solutions AB Present in Europe in other categories | – | Baha Baha 5 SuperPower Processing unit Baha 5 SuperPower Bodyworn cable Baha Smart App Baha 5 SuperPower Actuator unit Baha Fitting Software 7 | registered |
| BHM-Tech Produktionsgesellschaft m.b.H. Present in Europe in other categories | Austria | contact mini contact forte contact forte Alpha AN-Evo1 contact star evo1 | K243041 (2025) |
| Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | – | ADHEAR User Kit, Dove Silver ADHEAR Audio Processor, Model 701, Simply Black ADHEAR Headband, pink ADHEAR Audio Processor (701), Terra Brown, lock ADHEAR Audio Processor, Model 701, Test Device ADHEAR Configuration Software 1.0 Download | registered |
| Cochlear Americas Present in Europe in other categories | United States | Baha SoundArc Fun Colour Kit Baha SoundArc Small Baha SoundArc Medium Baha SoundArc Hair Matching Colour Kit Baha SoundArc Large Baha SoundArc Extra Large | K250215 (2025) |
| MEDTRONIC XOMED, INC. Present in Europe in other categories | United States | Otomag™ Alpha 2 Sound Processor | registered |
| Shenzhen Magnet Technology Co., Ltd | China | Ultroting | K261256 (2026) |
| EAR TECHNOLOGY CORPORATION | United States | TransEar | K062404 (2006) |
| SIGNUS Medizintechnik GmbH | Germany | TOSCA | registered |
| Sonitus Medical?Shanghai?Co., ltd. | China | SoundBite | registered |
| AMB Industri AB | Sweden | – | registered |
| CENOVA AB | Sweden | – | registered |
| DEMANT A/S | Denmark | – | registered |
| DENTSPLY SIRONA INC | United States | – | registered |
| EFS-EBERLE FEINWERKTECHN. SYSTEME GMBH & CO. KG | Germany | – | registered |
| ELOS MEDTECH AB | Sweden | – | registered |
| Elos Medtech Pinol A/S | Denmark | – | registered |
| Ing. Gerhard Fildan GmbH | Austria | – | registered |
| MILLSTONE MEDICAL OUTSOURCING LLC. | United States | – | registered |
| MeHow Innovative (Huizhou) Ltd. | China | – | registered |
| Med-El Elektromedizinische Geraete GmbH | Austria | – | K172460 (2018) |
| Medtronic, Inc. Present in Europe in other categories | United States | – | registered |
| Osseosound Holding AB | Sweden | – | registered |
| Osypka Medtec Inc. | United States | – | registered |
| QUALITY TECH SERVICES, LLC | United States | – | registered |
| Shenzen Magnet Technology Co.,Ltd | China | – | registered |
| Shokz Health Global Limited | Hong Kong SAR China | – | K253431 (2026) |
| Sophono, Inc. | United States | – | K153391 (2016) |
| Sounduct | France | – | K254296 (2026) |
| Stokvis Tapes Sweden | Sweden | – | registered |
| Yuh Jaan Industrial Co., Ltd. | Taiwan | – | registered |
| Zdeer Technology (Henan) Co., Ltd. | China | – | K260452 (2026) |
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