3DIEMME srl
IT-MF-000016005 · Italy · Cantù
3DIEMME srl is registered in the European database on medical devices as a manufacturer, with 261 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 261 |
|---|
Most frequent device types declared: RealGUIDE, STRMINSESTR-1, STRMINSESTR-2, STRMINSESTR-3, STRMTAGL-1, STRMTAGL-2, STRMTAGL-3, STRMTAGL-4, STRMTAGL-5, STRMTAGL-6.
Among these devices, 6 are declared reusable, 9 active, 9 with a measuring function.
Devices declared under this manufacturer
- BONE LEVELLER DRILL
- BONE MILL & SCREW
- CALIBRATED DRILLS
- CONNECTORS
- COUNTERSINK
- DRILL STOP
- DRIVERS
- FIXATION PIN
- FIXATION PIN DRILL
- IMPLANT MOUNT
- RealGUIDE
- START DRILL
Showing 12 of 261 declared devices.
Catalogue references include 3DM00604CAD2.10, 3DM00605AZTC40.10, 3DM00632TBLTRAY, 3DMUS00606ZIM31, 3DMUS00613.23.115, 3DMUS00615.
European nomenclature codes declared: Q010399, Q0199, S010401, Z119085.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | 3DIEMME SRL (IT) · FDA 3015173183 |
| Devices in EUDAMED | 261 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 261 |
|---|---|
| Found in the U.S. device database | 69 |
| Share | 26.4 % |
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: United States only. 3DIEMME srl is registered in the United States but was not found in the Canadian register.