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: FLOW CANNULA XXS with fixing for NIV/CPAP, BONNET for NIV size XXS Ø 22cm - Yellow, PROCEDURE PACK - NASAL CANNULA FOR NON-INVASIVE THERAPY, DISPOSABLE TNT COVER FOR MATTRESS 62x35 cm (Pack of 50), SYNC FLOW CANNULA XXS WHIT FASTENING SYSTEM.
Among these devices, 1 are declared sterile, 13 active.
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 | 86 |
| 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 |
|---|---|---|
IT350907 | amended | 2031-03-15 |