Biocartis NV
BE-MF-000003661 · Belgium · Mechelen
Biocartis NV is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
Most frequent device types declared: Idylla™ MSI Test.
Devices declared under this manufacturer
- Idylla™ CDx MSI Test
- Idylla™ Console
- Idylla™ Console Software Plus (CSW+)
- Idylla™ EGFR Mutation Test
- Idylla™ Hub
- Idylla™ Instrument
- Idylla™ MSI Test
Catalogue references include A0100/6, A0220/6, A0270/6, P0010, P1010, P1030.
European nomenclature codes declared: W02050116, W01060214, W01060299, W02050182.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BIOCARTIS NV (BE) · FDA 3009972873 |
| Devices in EUDAMED | 7 |
| Country of registration | Belgium |
Device-level evidence
| Devices with a numeric GTIN | 7 |
|---|---|
| Found in the U.S. device database | 3 |
| Share | 42.9 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BIOCARTIS NV |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 4 |
| First licensed | 2016-11-23 |
Licence types: Test Kit (3), System (1).
Licensed under: IDYLLA MOLECULAR DIAGNOSTICS SYSTEM, IDYLLA KRAS MUTATION TEST, IDYLLA EGFR MUTATION TEST, IDYLLA MSI TEST.
North American profile: Both markets. Biocartis NV is registered in both the United States and Canada.