Coris BioConcept
BE-MF-000024520 · Belgium · Gembloux
Coris BioConcept is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: Culture medium, K-13R15, K-15R11, K-15R15, K-15R5.
Devices declared under this manufacturer
- RESIST-1 MCR Multi Mobilised colistin resistance rapid test
- RESIST-3 O.K.N. Carbapenemases rapid test
- RESIST-5 O.K.N.V.I. Carbapenemases rapid test
- RESIST-BC
- ReSCape
Catalogue references include K-13R15, K-15R11, K-15R15, K-15R5, S-1001, S-1002.
European nomenclature codes declared: W0104080506, W0104080590, W0104010599, W0104010101.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 6 |
| Country of registration | Belgium |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 6 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | CORIS BIOCONCEPT |
North American profile: Canada only. Coris BioConcept holds a Canadian licence but was not found in the U.S. register.