Kerecis Limited
IS-MF-000001365 · Iceland · Isafjördur
Kerecis Limited is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 8 |
|---|
Among these devices, 8 are declared sterile.
Devices declared under this manufacturer
- Kerecis Omega3 Wound
- Kerecis™ Omega3 Wound
Catalogue references include 50200S00B0B, 50200S01B0B, 50200S02B0B, 50200S03B0B, 50200S04B0B, 50200S14B0B.
European nomenclature codes declared: M04041001.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 8 |
| Country of registration | Iceland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | KERECIS AG |
North American profile: Canada only. Kerecis Limited holds a Canadian licence but was not found in the U.S. register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
2258709CE01 | issued | 2030-10-01 |