Enzymatica AB
SE-MF-000002254 · Sweden · Lund
Enzymatica AB is registered in the European database on medical devices as a manufacturer, with 11 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class I | 11 |
|---|
Devices declared under this manufacturer
- ColdGuard
- ColdZyme
- ColdZyme Eucalyptus
- ColdZyme Strawberry
- ViruProtect
Catalogue references include 101002, 101010, 101015, 101101, 101115, 101202.
European nomenclature codes declared: V9017.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 11 |
| 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 | 10 |
|---|---|
| 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. Enzymatica AB was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.24/5406 | issued | 2029-03-06 |
EPT 0477.MDR.24/5405 | issued | 2029-03-06 |