GINEVRI srl
IT-MF-000034527 · Italy · Albano Laziale (Rome)
GINEVRI srl is registered in the European database on medical devices as a manufacturer, with 86 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 74 |
|---|---|
| Class IIb | 12 |
Most frequent device types declared: BABY SHUTTLE INTENSIVE CARE, BONNET for NIV - SMALL SIZES KIT (2XXS, 2XS, 2S), BONNET for NIV size XXS Ø 22cm - Yellow, ELIOS, FLOW CANNULA XXS with fixing for NIV/CPAP.
Among these devices, 1 are declared sterile, 13 active.
Devices declared under this manufacturer
- BABY SHUTTLE INTENSIVE CARE
- BONNET for NIV - LARGE SIZES KIT (2M, 2L, 2XL)
- BONNET for NIV size L Ø 35cm - Blue (Pack of 6)
- BONNET for NIV size S Ø 27cm - Green (Pack of 6)
- CLEAR GEL MATTRESS 60x34x0,9cm
- ELIOS
- FLOW CANNULA M with fixing for HFNC
- FLOW CANNULA M with fixing for NIV/CPAP
- FLOW CANNULA XS with fixing for HFNC
- FLOW CANNULA XS with fixing for NIV/CPAP
- MIZAR
- SMART CANNULA M Short Binasal Prongs SBP disposable
Showing 12 of 86 declared devices.
Catalogue references include 11282C73, 11659D73, 13612L73, 6968A73, 6969A73, 7634B.
European nomenclature codes declared: V0502, R02010102, T0207, T030199, R0301020302, R0301020301.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 86 |
| 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 | 86 |
|---|---|
| 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. GINEVRI srl was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT350907 | amended | 2031-03-15 |