Adaptis Spektra AB
SE-MF-000025764 · Sweden · Örbyhus
Adaptis Spektra AB is registered in the European database on medical devices as a manufacturer, with 61 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 61 |
|---|
Most frequent device types declared: Medium.
Devices declared under this manufacturer
- Axeltyngd Drake, rosa
- Axeltyngd Formsydd, Small
- Fidget-tub enkel, grå
- Fidget-tub enkel, röd
- Fidget-tub nyckelring, grå
- Fidget-tub nyckelring, orange
- Fidget-tub två kulor, lila
- Fidget-tub två kulor, röd
- Fippel, guld
- Fippelarmband Vuxen, Duvblå
- Tyglabyrint Rund
- Tyngdväst vuxen, X-Large
Showing 12 of 61 declared devices.
Catalogue references include 13000, 13017, 13023, 16002, 17001, 18102.
European nomenclature codes declared: V9099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 61 |
| 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 | 61 |
|---|---|
| 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. Adaptis Spektra AB was not found in either the U.S. or the Canadian register.