Oticon Medical AB
SE-MF-000000724 · Sweden · Askim
Oticon Medical AB is registered in the European database on medical devices as a manufacturer, with 133 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 133 |
|---|
Among these devices, 8 are declared sterile, 9 reusable, 21 active, 1 with a measuring function.
Devices declared under this manufacturer
- FLEX LINK GENIE MEDICAL BAHS 24.2
- Ponto 5 SuperPower, DBL
- Ponto 5 SuperPower, STG
- Ponto Soft band, bilateral, green
- Ponto Soft band, bilateral, indigo
- Ponto Soft band, green
- Ponto Soft band, navy
- Ponto Soft band, turquoise
- Screwdriver HexaDrive
- Soft band, bilateral, Light blue
- Soft band, bilateral, Red
- Softband 5, Bilateral M/L Red
Showing 12 of 133 declared devices.
Catalogue references include 173381, 173385, 185321, 223165, 223166, 275351.
European nomenclature codes declared: Y214599, Z12040282, L149099, Q030399, V0380, S9080.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Oticon Medical AB (SE) · FDA 3007367732 |
| Devices in EUDAMED | 133 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 133 |
|---|---|
| Found in the U.S. device database | 124 |
| Share | 93.2 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | OTICON MEDICAL AB |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 2 |
| First licensed | 2010-08-20 |
Licence types: System (2), Device Family (2).
Licensed under: PONTO BONE ANCHORED HEARING SYSTEM, GENIE MEDICAL FITTING SOFTWARE, PONTO 5 SUPERPOWER, SENTIO SYSTEM.
North American profile: Both markets. Oticon Medical AB is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 106872 0003 | issued | 2026-07-18 |