BIOSYNEX Swiss SA
CH-MF-000024717 · Switzerland · Delémont
BIOSYNEX Swiss SA is registered in the European database on medical devices as a manufacturer, with 41 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: BIOSYNEX COMBO COVID-FLU-RSV BSS.
Authorised representative in the Union: BIOSYNEX.
Devices declared under this manufacturer
- BIOSYNEX COMBO ADENO/ROTA BSS
- BIOSYNEX COVID-19 Ag BSS
- BIOSYNEX Legionella pneumophila BSS
- BIOSYNEX Legionella pneumophila BSX
- BIOSYNEX RSVTOP BSS
- BIOSYNEX Strep A BSX
- DRUGCHECK+ 10
- DRUGCHECK+ BUP
- DRUGCHECK+ OXY
- DRUGCHECK+ PCP
- DRUGCHECK+ THC
- DRUGCHECK+ TML
Showing 12 of 41 declared devices.
Catalogue references include 1140004_SW, 1140013_SW, 1140015_SW, 1140023_SW, 1140025_SW, 1150006BSS.
European nomenclature codes declared: W0102160511, W0102160599, W0105090108, W0102160508, W0105099007, W0102160505.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 41 |
| Country of registration | Switzerland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 41 |
|---|---|
| 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. BIOSYNEX Swiss SA was not found in either the U.S. or the Canadian register.