ELESTA SpA
IT-MF-000037909 · Italy · CALENZANO
ELESTA SpA is registered in the European database on medical devices as a manufacturer, with 15 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 15 |
|---|
Most frequent device types declared: EI GU2 0008 xxx, EI KT0 0005 020, EI KT0 0010 xxx.
Among these devices, 10 are declared sterile, 1 active.
Devices declared under this manufacturer
- ECHOLASER SMART INTERFACE
- Fiber Optic for PLA Long (Blue)
- Fiber Optic for PLA Long (Green)
- Fiber Optic for PLA Long (Red)
- Fiber Optic for PLA Long (Yellow)
- Fiber Optic for PLA Short (Blue)
- Fiber Optic for PLA Short (Green)
- Fiber Optic for PLA Short (Red)
- Fiber Optic for PLA Short (Yellow)
- GROOVE
- INFIX
- INTRODUCER
Showing 12 of 15 declared devices.
Catalogue references include EI GU2 0008 001, EI GU2 0008 002, EI GU2 0008 004, EI KT0 0005 020, EI KT0 0010 110, EI KT0 0010 220.
European nomenclature codes declared: Z12011080, A018002, A018003, V9099.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | ELESTA SPA (IT) · FDA 3015077548 |
| Devices in EUDAMED | 15 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 15 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 6.7 % |
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. ELESTA SpA is registered in the United States but was not found in the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT343885 | issued | 2030-07-08 |