Mölnlycke Health Care AB
SE-MF-000014042 · Sweden · Mölndal
Mölnlycke Health Care AB is registered in the European database on medical devices as a manufacturer, with 48 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 43 |
|---|---|
| Class IIb | 5 |
Among these devices, 7 are declared sterile, 2 active.
Devices declared under this manufacturer
- Adhesive OP-Sheet ISCC
- Adhesive OP-Towel ISCC
- Camera Drape
- EasyWarm Active Self-Warming Blanket
- Exufiber
- Mesoft
- Mestopore
- Mestopore S
- Mölnlycke Tortoise Turning and Positioning System
- Mölnlycke Z-Flex Fluidized Heel Boot
- Mölnlycke Z-Flo Fluidized Positioner, Adult
- Mölnlycke Z-Flo Fluidized Positioner, Neo and Peds
Showing 12 of 48 declared devices.
Catalogue references include 1400122, 1400206, 1401003, 1401008, 156300, 157000.
European nomenclature codes declared: M0202030102, V080302, T020199, M04010199, V0811, M040204.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 48 |
| 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 | 48 |
|---|---|
| Found in the U.S. device database | 21 |
| Share | 43.8 % |
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. Mölnlycke Health Care AB was not found in either the U.S. or the Canadian register.