BIONEN SRL
IT-MF-000018461 · Italy · Firenze
BIONEN SRL is registered in the European database on medical devices as a manufacturer, with 430 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 430 |
|---|
Among these devices, 86 are declared sterile.
Devices declared under this manufacturer
- Cavi con attacco a bottone
- Cavi di collegamento
- Cavo di collegamento per elettrodi a ponte
- Cuffie EEG
- Cuffie per EEG
- Elettrodo a coppetta
- Elettrodo a coppetta in Ag/AgCl monouso
- Elettrodo a ponte in Ag/AgCl
- Elettrodo ad ago Concentrico, sterile (monouso)
- Elettrodo ad ago Monopolare ipodermico, sterile (monouso)
- Elettrodo ad ago Monopolare isolato, sterile (monouso)
- Elettrodo ad ago subdermale (monouso)
Showing 12 of 430 declared devices.
Catalogue references include 0005.000, 0013.C01-BPP-S-I, 0013.C03-BPP-S-E, 0013.F02-BQK-K-I, 0021.022-L13, 0021.030-200.
European nomenclature codes declared: N01010203, N010101, Z1399, N01010299, N010180, N010199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIONEN SRL (IT) · FDA 3008617703 |
| Devices in EUDAMED | 430 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 430 |
|---|---|
| Found in the U.S. device database | 1 |
| Share | 0.2 % |
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. BIONEN SRL is registered in the United States but was not found in the Canadian register.