Fogless International AB
SE-MF-000001616 · Sweden · Vaggeryd
Fogless International AB is registered in the European database on medical devices as a manufacturer, with 34 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 34 |
|---|
Most frequent device types declared: 702, 703, 705, 707; 708, 710.
Devices declared under this manufacturer
- SPIRO
Showing 12 of 34 declared devices.
Catalogue references include 702-5K, 708-2K, 710-1K, 710-2K, 710-5K, 711-1K.
European nomenclature codes declared: R90060202, R040201, R040299,R900680, R040201,R900680, R900680, L031305.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | FOGLESS INTERNATIONAL AB (SE) · FDA 3014054118 |
| Devices in EUDAMED | 34 |
| Country of registration | Sweden |
Device-level evidence
| Devices with a numeric GTIN | 34 |
|---|---|
| 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: United States only. Fogless International AB is registered in the United States but was not found in the Canadian register.