BIOSYNEX
FR-MF-000014073 · France · ILLKIRCH-GRAFFENSTADEN
BIOSYNEX is registered in the European database on medical devices as a manufacturer, with 137 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| other | 108 |
|---|---|
| Class IIb | 15 |
| Class IIa | 14 |
Most frequent device types declared: Gouttes Oculaires Hydratantes, MEMOCERVICAL , BIOSYNEX AMPLIQUICK Parasitology Lite, BIOSYNEX AMPLIQUICK Lysis, BORELLI.
Among these devices, 15 are declared sterile, 1 active, 1 with a measuring function.
No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 137 |
| Country of registration | France |
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 002187 0009 | issued | 2028-09-25 |
030/MDR | issued | 2027-06-05 |