BIOMEC SRL
IT-MF-000021622 · Italy · COLICO (LC)
BIOMEC SRL is registered in the European database on medical devices as a manufacturer, with 312 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 220 |
|---|---|
| Class IIa | 92 |
Most frequent device types declared: ACCESSORI PER IMPLANTOLOGIA DENTALE - FASE PROTESICA, ACCESSORI PER IMPLANTOLOGIA DENTALE - STRUMENTAZIONE, COMPONENTISTICA PROTESICA CHIRURGICA A BREVE TERMINE - VITE DI GUARIGI, COMPONENTISTICA PROTESICA IMPIANTABILE IN TITANIO, COMPONENTISTICA PROTESICA NON CHIRURGICA A LUNGO TERMINE - CUFFIE E CA.
Among these devices, 125 are declared sterile, 220 implantable, 93 with a measuring function.
Devices declared under this manufacturer
- DIGITAL ANALOGUE MULTIFIX - PACK 5 PCS
- FIXO LINK MINI WIN-K MINI H. 1.5
- HEALING ABUTMENT WIN-K REGULAR H. 2.5
- IMP. BASAL MULTIFIX 0° D. 3.50 L. 12.0
- IMP. BASAL MULTIFIX 0° D. 4.00 L. 22.0
- IMP. BASAL MULTIFIX 15° D. 3.50 L. 18.0
- IMP. COMPRESSIVE MULTIFIX 15° D. 4.00 L. 6.0
- IMP. PSK-EVO STANDARD CONICAL D. 4.75 L. 13.0
- IMP. PSK-EVO STANDARD CONICAL D. 4.75 L. 8.5
- IMP. WIN ZYGOMA D. 3.75 L. 47.5
- IMP. WIN-K CONICAL OS CONNECTION D. 5.00 L. 10.0
- MANUAL DRIVER INSERTER D8 WIN-K MEDIUM
Showing 12 of 312 declared devices.
Catalogue references include BSIMF3500120, BSIMF4000220, COMMF4015060, PKES47130, WIK352007, WIK356012.
European nomenclature codes declared: P01020101, P010299, L159099, Q010280, P01020180.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 312 |
| 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 | 312 |
|---|---|
| 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. BIOMEC SRL was not found in either the U.S. or the Canadian register.