PROMETHEUS S.r.l.
IT-MF-000028429 · Italy · Parma
PROMETHEUS S.r.l. is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 10 |
|---|
Most frequent device types declared: TD-01.01.
Among these devices, 6 are declared sterile, 4 active.
Devices declared under this manufacturer
- Ematik Lab Kit
- Ematik Patch
- Partisel
- Partisel Kit
Catalogue references include EL-01, ELK-01, EP-01, K-01, K02, PA-01.
European nomenclature codes declared: B06, A010199, V0599.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 10 |
| Country of registration | Italy |
⚠️ 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. PROMETHEUS S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030173-00 | issued | 2031-03-05 |