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
| Class IIa | 14 |
|---|---|
| Class IIb | 15 |
Most frequent device types declared: BIOSYNEX AMPLIFLASH MALARIA, BIOSYNEX AMPLIQUICK Leptospira, BIOSYNEX AMPLIQUICK Lysis, BIOSYNEX AMPLIQUICK Parasitology Lite, BIOSYNEX AMPLIQUICK STI Panel I.
Among these devices, 15 are declared sterile, 1 active, 1 with a measuring function.
Devices declared under this manufacturer
- AMNIOQUICK CARD
- AMNIOQUICK DUO+
- BIOSYNEX AMPLIQUICK Leptospira
- BIOSYNEX AMPLIQUICK Lysis
- BIOSYNEX AMPLIQUICK Parasitology Lite
- BIOSYNEX AMPLIQUICK Protozoans
- BORELLI
- Control Set for rapid SARS-CoV-2 PCR
- ELIPROM
- Hydrableu
- MEMOCERVICAL
- MYCETCOLOR
Showing 12 of 137 declared devices.
Catalogue references include 10025, 1090004_C, 1090005, 3150059_SEC02, 3150067_SEC02, 3150078_SEC01.
European nomenclature codes declared: Q02030299, V080399, W01050704, W0102060405, W0104030405, W0102100604.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 137 |
| 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 | 137 |
|---|---|
| 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.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G10 002187 0009 | issued | 2028-09-25 |
030/MDR | issued | 2027-06-05 |