Bordier Affinity Products SA
CH-MF-000025247 · Switzerland · Crissier
Bordier Affinity Products SA is registered in the European database on medical devices as a manufacturer, with 32 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Authorised representative in the Union: Leman Diagnostics SARL.
Devices declared under this manufacturer
- Acanthocheilonema viteae IgG ELISA
- Anisakidae IgG ELISA
- Ascaris IgG ELISA
- Aspergillus fumigatus IgG ELISA
- Echinococcus granulosus IgG ELISA
- Echinococcus multilocularis (Em18) IgG ELISA
- Echinococcus multilocularis (Em2- Em18) IgG ELISA
- Echinococcus multilocularis (Em2-Em18) IgG ELISA
- Fasciola hepatica IgG ELISA
- Microsporidia IFAT
- Schistosoma mansoni IgG ELISA
- Strongyloïdes ratti IgG ELISA
Showing 12 of 32 declared devices.
Catalogue references include 6100, 9250, 9310, 9350, 9400, 9600.
European nomenclature codes declared: W0105050299, W0105050204, W0105050206, W0105060301, W0104050299, W0105050203.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BORDIER AFFINITY PRODUCTS SA (CH) · FDA 3003718445 |
| Devices in EUDAMED | 32 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 32 |
|---|---|
| Found in the U.S. device database | 28 |
| Share | 87.5 % |
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: United States only. Bordier Affinity Products SA is registered in the United States but was not found in the Canadian register.