ComfortSystem Scandinavia AB
SE-MF-000038482 · Sweden · Huskvarna
ComfortSystem Scandinavia AB is registered in the European database on medical devices as a manufacturer, with 35 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 35 |
|---|
Most frequent device types declared: COMFORTABEL Sängryggstöd, COMFORTABEL Sängryggstöd tillbehör, Gavlar 3-60, Integrerad grind COMFORT 3-60, QVINTETT Vårdsäng CS4.
Among these devices, 14 are declared active.
Devices declared under this manufacturer
- Comfortabel Compact Sängryggstöd 90cm
- Comfortabel Side Sängryggstöd 105cm
- Comfortabel Side Sängryggstöd 90cm
- Gavlar OPAL 3-60, 90cm
- Gavlar Safir 3-60, 105cm
- Integrerad grind COMFORT 3-60, 200cm
- Integrerad grind COMFORT 3-60, 220cm
- Integrerad grind COMFORT 4-40, 200cm
- QVINTETT vårdsäng CS4, 90cm
- QVINTETT vårdsäng H-Large, CS4F-2 105cm, 90cm
- QvickUp Uppresningsstöd
- Stod och Vändhandtag 75x57cm
Showing 12 of 35 declared devices.
Catalogue references include 457105, 498205, 498220, 499205, 8014, CS67.
European nomenclature codes declared: V08068002, V08068001, V080699, V08060101, V08068099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 35 |
| 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 | 35 |
|---|---|
| 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. ComfortSystem Scandinavia AB was not found in either the U.S. or the Canadian register.