Digitec S.r.l.
IT-MF-000007792 · Italy · Lecco
Digitec S.r.l. is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 19 |
|---|---|
| Class IIa | 2 |
Among these devices, 21 are declared active, 20 with a measuring function.
Devices declared under this manufacturer
- 3D-Cam Pilot
- DRF4343-DT
- ERACLE
- INSIDE C-ARM
- INSIDE_SW
- O-D4000WS
- ODIS
- TEIA
- TESEO
- VDX Next
Showing 12 of 21 declared devices.
Catalogue references include 3DCam C, ARM_01_006, ARM_01_018, DRF_01_001, DRF_01_002, DRF_01_010.
European nomenclature codes declared: Z11031192, Z11069092.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 21 |
| 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 | 21 |
|---|---|
| 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. Digitec S.r.l. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1450755 1 | supplemented | 2027-12-28 |