Embreis AB
SE-MF-000003023 · Sweden · Taby
Embreis AB is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 20 |
|---|
Devices declared under this manufacturer
- Comfit AFO - Classic Pad kit L
- Comfit AFO - Custom
- Comfit AFO - Extra Strong, Custom
- Comfit AFO - Extra Strong, Right L Wide
- Comfit AFO - Extra Strong, Right S
- Comfit AFO - Testkit Standard
- Comfit AFO - Testkit Wide
- Comfit AFO, Left L
- Comfit AFO, Left L Wide
- Comfit AFO, Left S
- Comfit AFO, Right L
- Comfit AFO, Right L Wide
Showing 12 of 20 declared devices.
Catalogue references include E8061-KIT, E806100, E806113, E806127, E806157, E806167.
European nomenclature codes declared: Y06120602, Y062409, Y061280.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 20 |
| Country of registration | Sweden |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 20 |
|---|---|
| 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. Embreis AB was not found in either the U.S. or the Canadian register.