Sterisol AB
SE-MF-000019930 · Sweden · Vadstena
Sterisol AB is registered in the European database on medical devices as a manufacturer, with 18 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 18 |
|---|
Among these devices, 18 are declared sterile.
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 | STERI SOLUTIONS (PTY) LTD (ZA) · FDA 3043521642 |
| Devices in EUDAMED | 18 |
| 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 |
|---|---|---|
C541396 | issued | 2027-08-25 |