Arcomed AG
CH-MF-000035749 · Switzerland · Koten
Arcomed AG is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 16 |
|---|
Among these devices, 9 are declared active.
Authorised representative in the Union: Susen Akermann.
Devices declared under this manufacturer
- UniQueCONCEPT 1 Module
- UniQueCONCEPT 3 Module
- UniQueCONCEPT 4 Module
- UniQueCONCEPT 5 Module
- UniQueCONCEPT 6 Module
- UniQueCONCEPT 8 Module
- UniQueDOC 1 Module
- UniQueDOC 2 Module
- UniQueDOC 3 Module
- UniQueDOC 4 Module
- UniQueDOC 5 Module
- UniQueDOC 6 Module
Showing 12 of 16 declared devices.
Catalogue references include 5310-5413, 5310-5414, 5310-5415, 5320-4, 5411, 5412.
European nomenclature codes declared: V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 16 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 16 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Arcomed AG was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G15 013006 0024 | issued | 2031-07-08 |
G15 013006 0024 | amended | 2031-07-08 |