Mikai s.p.a.
IT-MF-000030732 · Italy · Genova
Mikai s.p.a. is registered in the European database on medical devices as a manufacturer, with 2 012 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 1 272 |
|---|---|
| Class IIa | 740 |
Most frequent device types declared: Accessorio, Arco e anello alluminio, Arco e anello carbonio, Barra, ClickIt ER accessory.
Among these devices, 2 010 are declared sterile, 1 272 implantable.
Devices declared under this manufacturer
- ADATTATORE DEL SUPPORTO PER RACCORDI AD ARCO ST
- ANELLO ESAPODALICO ACCUCLICK Ø100MM ST
- ARCO PELVICO PICCOLO ST
- BARRA FILETTATA M6 L50MM ST
- BARRA MOBILE BILATERALE L80-100MM ST
- BSS FOOT-VITE A COMPRESSIONE Ø3.0MM L26MM FILETTO LUNGO F6MM ST
- VITE A COMPRESSIONE CON TESTA Ø4.0MM L40MM FILETTO COMPLETO ST
- VITE A COMPRESSIONE CON TESTA Ø7.0MM L95MM FILETTO CORTO F19MM ST
- VITE A COMPRESSIONE HEADLESS INCLINATA Ø2.5MM L20MM FILETTO COMPLETO S
- VITE A COMPRESSIONE HEADLESS INCLINATA Ø4.0MM L24MM FILETTO COMPLETO S
- VITE A COMPRESSIONE HEADLESS Ø4.0MM L36MM FILETTO COMPLETO ST
- VITE A COMPRESSIONE HEADLESS Ø5.0MM L60MM FILETTO COMPLETO ST
Showing 12 of 2 012 declared devices.
Catalogue references include 5.2401A.100ST, 5000076ST, 5006542SST, BSS30626ST, BSS40024VST, BSS40036CST.
European nomenclature codes declared: P09120603, P0912040102, P0912040101, P09120601, P09120301, P09120499.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 2 012 |
| 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 | 2 012 |
|---|---|
| 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. Mikai s.p.a. was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
ITH 1343576 1 | issued | 2030-01-23 |