WELCARE INDUSTRIES S.p.A.
IT-MF-000020870 · Italy · Milano (MI)
WELCARE INDUSTRIES S.p.A. 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 IIb | 6 |
|---|---|
| Class IIa | 4 |
Among these devices, 6 are declared sterile.
Devices declared under this manufacturer
- Optigard
- Optigard Double Foam
- Optigard Safety Straps
- Sinaqua x 12
- UCGel™ Debridement 15ml, 20 units
- UCS Debridement x 10
- UCS Debridement x 30
- UCSol™ DEBRIDEMENT, 500 mL
- UCSol™ Debridement 150 mL
- UCSol™ Debridement, 350ml
Catalogue references include 91000, 91002, 91003, 95150F, 95150G, 95160.
European nomenclature codes declared: M040499, T0306.
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. WELCARE INDUSTRIES S.p.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
EPT 0477.MDR.23/5201.1 | reissued | 2028-07-09 |