BEN S.R.L. BIOCHEMICAL ENTERPRISE
IT-MF-000021057 · Italy · Milano
BEN S.R.L. BIOCHEMICAL ENTERPRISE is registered in the European database on medical devices as a manufacturer, with 14 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: VLR0101, VLR0102, VLR0103, VLR0104, VLR0105.
Devices declared under this manufacturer
- CALCIUM CHLORIDE
- CoaCC Calcium Chloride
- Coag Cleaning Solution
- Coag Diluent
- Coag Kaolin
- FERRITIN
- FERRITIN CALIBRATOR
- G6PDH-RED CELL LYSING REAGENT (only for automation)
- KAPPA LIGHT CHAINS (FREE+BOUND)
- LAMBDA LIGHT CHAINS (FREE+BOUND)
- OXALATE URINE PURIFIER
- PLASMAPROTEINS CALIBRATOR 5 concentrations
Showing 12 of 14 declared devices.
Catalogue references include C731, C734, C736, E05Y0001, E05Y0010, E05Y0101.
European nomenclature codes declared: W0103020999, W0102152003, W0102010109, W0103020901, W01019099, W0102152203.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 14 |
| 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 | 14 |
|---|---|
| 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. BEN S.R.L. BIOCHEMICAL ENTERPRISE was not found in either the U.S. or the Canadian register.