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BRCA 1/2 Panel
EUDAMEDClass IVD General (EU MDR)
Ref G2MBR00001-ill,G2MBR00001-MG,G2MBR00001-TFModel G2MBR00001
Identity
- Trade Name
- BRCA 1/2 Panel EUDAMED
- Device Name
- BRCA 1/2 Panel EUDAMED
- Model / Reference
- G2MBR00001 EUDAMEDG2MBR00001-ill,G2MBR00001-MG,G2MBR00001-TF EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G2MBR00001K8 EUDAMED
- Basic UDI-DI
- B-G2MBR00001K8 EUDAMED
- EMDN Code
- W01060203 BRCA 1+2 EUDAMED
Classification
- Device Class
- Class IVD General 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
No
EUDAMED
Surgical Instrument
No
EUDAMED
BRCA 1/2 Panel by Genes 2Me Private Limited — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-G2MBR00001K8 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Genes 2Me Private Limited
- EUDAMED SRN
- IN-MF-000035953
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 183e1787-3111-4ff4-80e5-6596aa3cb527 61 fields · synced Jul 15, 2026
- EUDAMED 183e1787-3111-4ff4-80e5-6596aa3cb527-1 61 fields · synced Jun 10, 2026