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: BONE PROFILER, DRILL, SCREW TAP, TISSUE PUNCH, COUNTERSINK, TITANIUM BASE, INVISIBASE, SIR LINK, BT LINK, BT LINK BASE, BT SCREW, BT SCREW ETCHED, TITANIUM PINS, CUTTER STOP, CUTTER STOP RING, 3D ASSEMBLY DEVICE SPACER, CLASS I MANUAL DRIVER.

Among these devices, 481 are declared sterile, 1 898 implantable, 90 reusable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment register	Not found in the FDA register
Devices in EUDAMED	3 156
Country of registration	Italy

⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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

Other manufacturers in Italy

All Italy manufacturers →