BIOSYNEX
FR-MF-000042615 · France · CROISSY-BEAUBOURG
BIOSYNEX is registered in the European database on medical devices as a manufacturer, with 173 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab, IMMUNO-TROL i-Tracker Anti-Infliximab Total Ab, IMMUNO-TROL i-Tracker Anti-Risankizumab, IMMUNO-TROL i-Tracker Etanercept, IMMUNO-TROL i-Tracker Risankizumab.
Devices declared under this manufacturer
- Cardio-Lisa IgG
- FIDIS Connective Profile
- HUMAN & ANIMAL RHEUMA-LISA IgM
- IMMUNO-TROL Golimumab
- IMMUNO-TROL i-Tracker Anti-Infliximab Total Ab
- LISA-TRACKER Anti-Infliximab
- LISA-TRACKER Anti-Rituximab
- LISA-TRACKER Anti-Secukinumab
- LISA-TRACKER Anti-Trastuzumab
- LISA-TRACKER Infliximab
- LISA-TRACKER Rituximab
- LKM IFA Positive Control
Showing 12 of 173 declared devices.
Catalogue references include CTO 003-50, HM 001PE, HM 030-1X05, LTI 002-96, LTR 003-48, LTS 003-48.
European nomenclature codes declared: W0102152011, W0102080799, W0102152001, W0102080701, W0102109099, W0102080702.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 173 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 173 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOSYNEX. |
North American profile: Canada only. BIOSYNEX holds a Canadian licence but was not found in the U.S. register.