BIOPSYBELL SRL
IT-MF-000011601 · Italy · mirandola
BIOPSYBELL SRL is registered in the European database on medical devices as a manufacturer, with 3 231 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 3 231 |
|---|
Most frequent device types declared: CH2210EC, GM2215EC-Y, KMVT1315001C-A, KRVT1512200CBP-A, MN2112EC.
Among these devices, 3 231 are declared sterile, 748 active.
Devices declared under this manufacturer
- BIOPSYWEST
- CHIBELL
- DISKOM INTRODUCER
- FRANSEEN
- FULLY REMOVE
- GAMMA
- KYPHOKIT DRILL
- MOON
- OPTYFILL
- RENOVA SPINE FAST ACCESS SYSTEM
- RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP
- SCREWFIX
Showing 12 of 3 231 declared devices.
Catalogue references include CH2310EC, KMVT1315001C-A, OPF1110C-01EM, RESWTR0812C, SBDTR2025EC, SF092002C1D.
European nomenclature codes declared: A01020102, A019011, A0102010101, A0102010102, K010301, A01020201.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | BIOPSYBELL S.R.L. (IT) · FDA 9617616 |
| Devices in EUDAMED | 3 231 |
| Country of registration | Italy |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 3 231 |
|---|---|
| Found in the U.S. device database | 782 |
| Share | 24.2 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
IT349638 | issued | 2030-02-09 |