audifon GmbH & Co. KG
DE-MF-000008355 · Germany · Kölleda
audifon GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 443 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 443 |
|---|
Most frequent device types declared: Dome, Hearing aid, Mobile App, Moblie App, Noiser.
Among these devices, 349 are declared active.
Devices declared under this manufacturer
- HE-S
- KINDaluna 1100
- KINDaluna 1400
- KINDfit 5.x
- KINDwings 1400
- ThinTube
- kami ITE V50
- kami ITE V70
- kami XS
- rega CIC
- risa R Li
- sino ITE V60
Showing 12 of 443 declared devices.
Catalogue references include 021870-396, 023169-9041-313-1720, 023175-A744-325-1720, 023301-9263-327-358, 023301-9265-334-358, 023305-9112-334-358.
European nomenclature codes declared: Y2145060102, Y2145060101, Y214580, Y2145060201, Y2145060203, Y214599.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | AUDIFON - GMBH & CO.KG (DE) · FDA 3006076696 |
| Devices in EUDAMED | 443 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | AUDIFON GMBH & CO. KG |
North American profile: Both markets. audifon GmbH & Co. KG is registered in both the United States and Canada.