BenCorpp Srl
IT-MF-000023046 · Italy · Mirandola
BenCorpp Srl is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 12 |
|---|
Most frequent device types declared: Balloon Dilation System, Trach-HME with Built-in Speech Valve.
Among these devices, 7 are declared sterile.
Devices declared under this manufacturer
- DILATLAX® - Balloon Dilation System
- MEDIFLUX HCH F6 - Trach-HME with Built-in Speech Valve
- MorbideX® - Protective cushion Pediatric
- MorbideX® – Protective cushion Adult
- SpeVaX® - Trach-HME with Built-in Speech Valve
Catalogue references include HCHF6, MBX-01, MBX-02, TLA 007-30-500, TLA 010-40-500, TLA 014-40-500.
European nomenclature codes declared: Q030399, R040201, R030180.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 12 |
| 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 | 12 |
|---|---|
| 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. BenCorpp Srl was not found in either the U.S. or the Canadian register.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
0425-MDR-030039-00 | issued | 2028-08-02 |
0425-MDR-030038-00 | issued | 2028-08-02 |