Stretch Care AB
SE-MF-000007735 · Sweden · Malmö
Stretch Care AB is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Among these devices, 12 are declared active.
Devices declared under this manufacturer
- Amni Care
- Blåappen
- Blåappen [SV]
Catalogue references include 6.2.5.46103, 7.0.0.49204, 7.3.0.58205, 7.4.0.61086, 7.5.0.63180, 8.1.0.8.
European nomenclature codes declared: Z12040182, Z12040192.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| 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 | 12 |
|---|---|
| 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. Stretch Care AB was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 112821 0001 | issued | 2028-08-20 |