SOFTLINE-Schaum GmbH & Co. KG
DE-MF-000014549 · Germany · Storkow
SOFTLINE-Schaum GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 384 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 384 |
|---|
Most frequent device types declared: Arthrodesenkissen, Klinikmatratzen Prophylaxe/Therapie, Klinikmatratzen Standard, Pflegebettmatratzen Prophylaxe, Pflegebettmatratzen Therapie.
Devices declared under this manufacturer
- CARFLEX
- CARGUMIXT
- CUBE FLEXi
- CUBE GEL
- CUBE PRO XXL
- DEKUCARE VISCO RZ DUPLEX
- DEKULAST BASIC
- DEKULAST XXL RZ
- Fersenfreilagerung M
- Halbmondkissen M
- INCUBE BASIC
- Rückenlagerungskissen M
Showing 12 of 384 declared devices.
Catalogue references include K31100, K35433, K35444, K46802, M19431, M36601.
European nomenclature codes declared: V080702, V08030102, V080302, V08068099, Y180999, V0899.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 384 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 384 |
|---|---|
| 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. SOFTLINE-Schaum GmbH & Co. KG was not found in either the U.S. or the Canadian register.