Wolff Kunststoffe GmbH
DE-MF-000017849 · Germany · Mörlenbach
Wolff Kunststoffe GmbH is registered in the European database on medical devices as a manufacturer, with 194 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 194 |
|---|
Most frequent device types declared: 1-Valve / 1-Chamber, 2-Valve / 2-Chamber, 4 Valve / 4 Chamber, Accessories, C4 / 1-or 4 chamber with central valve.
Devices declared under this manufacturer
- CONFORM® Carrying Box (7,5 cm)
- CONFORM® Carrying Box (SKD)
- CONFORM® Carrying Box (SKH)
- CONFORM® Cover Plate AP4
- CONFORM® Cover Plate to supress 4 cells
- CONFORM® Cushion Cover Waterproof for SKD XXL
- CONFORM® Cushion Cover Waterproof for SKH XXL
- CONFORM® Cushion Cover Waterproof for SKN/SKD/SKH
- CONFORM® Cushion Cover for C4
- CONFORM® Cushion Cover for SKD XXL
- CONFORM® Cushion Cover for SKH XXL
- CONFORM® Medical Air Cushion
Showing 12 of 194 declared devices.
Catalogue references include SKD 4540/4, SKH 4030, SKH 4035/4, SKH XXL 6050, SKH XXL 6560/2, SKN 4035.
European nomenclature codes declared: V080302, V08030102, V080702, V08030101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 194 |
| 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 | 194 |
|---|---|
| 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. Wolff Kunststoffe GmbH was not found in either the U.S. or the Canadian register.