Sunmedic AB
SE-MF-000012997 · Sweden · Vellinge
Sunmedic AB is registered in the European database on medical devices as a manufacturer, with 44 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIb | 42 |
|---|---|
| Class IIa | 2 |
Most frequent device types declared: MP 24 VivaFoam™ 25x15x3.2, VivaFoam™ Filler 25x15x3.2, VivereX™ Dressing FC 10x20, VivereX™ Dressing FC 16x21, VivereX™ Dressing FC 16x31.
Among these devices, 42 are declared sterile, 17 active.
Devices declared under this manufacturer
- VivaFoam™
- VivereX+™ NPWT pump
- VivereX™
- VivereX™ Dressing FC 10x20
- VivereX™ NPWT Pump
Showing 12 of 44 declared devices.
Catalogue references include PDI6001221, PDI600123, PDI600124, PDI600225, PDI600226, PDI605223.
European nomenclature codes declared: M04040702, M04040702,Z12019003, M04040601, Z12019003.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | SUNMEDICA (US) · FDA 1721819 |
| Devices in EUDAMED | 44 |
| Country of registration | Sweden |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 44 |
|---|---|
| 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CERT-000147 | issued | 2031-07-20 |