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: VivereX™ Dressing FC 10x20, VivereX™ MP FC 26x26, VivereX™ Pump + 2 FC Dressings 16x16, MP 24 VivaFoam™ 25x15x3.2, VivereX™ MP FC 10x40.
Among these devices, 42 are declared sterile, 17 active.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | SUN MEDICAL CO., LTD. (JP) · FDA 8030419 |
| Devices in EUDAMED | 44 |
| Country of registration | Sweden |
⚠️ A similar name exists in the FDA register. We do not assert that it is the same company — the two registers share no common identifier, and a name alone is not proof. This entry needs a human check.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CERT-000147 | issued | 2031-07-20 |