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Belgium·BE-MF-000003661
Last updated September 17, 2026
Information
- Country
- Belgium
- Address
- 11B, Generaal De Wittelaan, Mechelen, Belgium
- Website
- www.biocartis.com
- —
- —
- [email protected]
- Phone
- +32 15 632 600
- PRRC Contact
- Annelies Cassiers
- EUDAMED SRN
- BE-MF-000003661
- FDA FEI Number
- 3009972873
- DUNS Number
- 400686169
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Idylla™ Respiratory (IFV-RSV) Panel | 1.0 | FDA UDI | Class II | Unknown |
| Idylla™ MSI Test | 2 | FDA UDI | Class II | Active |
| Idylla™ Hub | P1030 | EUDAMED | Class A | Active |
| Idylla™ Console Software Plus (CSW+) | P2040 | EUDAMED | Class A | Active |
| Idylla™ Instrument | P0010 | EUDAMEDFDA UDI | Class A | Active |
| Idylla™ CDx MSI Test | A0220/6 | EUDAMED | Class C | Active |
| Idylla™ Console | P1010 | EUDAMEDFDA UDI | Class A | Active |
| Idylla™ EGFR Mutation Test | A0270/6 | EUDAMED | Class C | Active |
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