Identity
- Trade Name
- Idylla™ EGFR Mutation Test EUDAMED
- Device Name
- Idylla™ EGFR Mutation Test EUDAMED
- Model / Reference
- A0270/6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415219000843 EUDAMED
- Basic UDI-DI
- 5415219A0270CC EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Idylla™ EGFR Mutation Test by Biocartis NV — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5415219A0270CC | Class C | Active |
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Manufacturer
- Manufacturer
- Biocartis NV
- EUDAMED SRN
- BE-MF-000003661
Sources (1)
- EUDAMED ee849a12-0cf5-4ab1-9691-830fabdfeb0a 61 fields · synced Jun 19, 2026