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 was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 18 |
|---|
Most frequent device types declared: Single-use eyewash bottle containing sterile saline solution for ocula.
Among these devices, 18 are declared sterile.
Devices declared under this manufacturer
- Sterisol Rincage Oculaire
- Sterisol Ögondush
- WERO AUGENSPULFASHE
Showing 12 of 18 declared devices.
Catalogue references include 280019, 4630, 4641, 4655, 4661, 4665.
European nomenclature codes declared: A03040202.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 |
| 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 | 18 |
|---|---|
| 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. Sterisol AB was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
C541396 | issued | 2027-08-25 |