BIOTEC S.R.L.
IT-MF-000026774 · Italy · Povolaro di Dueville
BIOTEC S.R.L. is registered in the European database on medical devices as a manufacturer, with 3 156 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 1 898 |
|---|---|
| Class IIa | 1 258 |
Most frequent device types declared: ABUTMENT, LOCATOR ABUTMENT, CONNECTOR ABUTMENT, RING ABUTMENT, BT4 ABU, BONE PROFILER, DRILL, SCREW TAP, TISSUE PUNCH, COUNTERSINK, CLASS I MANUAL DRIVER, IMPRESSION POST, IMPRESSION POST PRO, IMPRESSION POST TWO, IMPRESSION , INTRA-ORAL SCAN ABUTMENT, SKELETAL SCAN ABUTMENT.
Among these devices, 481 are declared sterile, 1 898 implantable, 90 reusable.
Catalogue references include 108IW50M, 261IR6A0, 266IR4G0, 323IM0R0, 352KR2A0, 434HS480.
European nomenclature codes declared: Q010299, L159099, P01020101, Z12119099, P09120604.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 3 156 |
| Country of registration | Italy |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
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. BIOTEC S.R.L. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
088-00-00-MDR | issued | 2030-12-18 |
008-00-04-MDR | supplemented | 2027-12-20 |
007-00-06-MDR | supplemented | 2027-12-20 |