TENACTA GROUP S.p.A.
IT-MF-000039868 · Italy · Azzano S. Paolo (BG)
TENACTA GROUP S.p.A. 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: Fascia Riscaldante Ricaricabile.
Among these devices, 18 are declared active.
Devices declared under this manufacturer
- Fascia riscaldante ricaricabile cervicale
- Fascia riscaldante ricaricabile lombare
- faja termica recargable cervical
- faja termica recargable lumbar
- heat wrap rechargeable cervical
- heat wrap rechargeable lumbar
Showing 12 of 18 declared devices.
Catalogue references include 26070, 26078, 26081, 26084, 26086, 26108.
European nomenclature codes declared: Z12069099.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 18 |
| 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 | 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. TENACTA GROUP S.p.A. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
263/MDR | supplemented | 2031-01-22 |