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Clinical Exome Sequencing (CES) Expanded Panel
EUDAMEDClass IVD General (EU MDR)
Ref G2MCES07001-ill G2MCES07001-MG G2MCES07001-TF G2MCES07001(WES) ill G2MCES07001(WES) MG G2MCES07001(WES) TFModel G2MCES07001
Identity
- Trade Name
- Clinical Exome Sequencing (CES) Expanded Panel EUDAMED
- Device Name
- Clinical Exome Sequencing (CES) Expanded Panel EUDAMED
- Model / Reference
- G2MCES07001 EUDAMEDG2MCES07001-ill G2MCES07001-MG G2MCES07001-TF G2MCES07001(WES) ill G2MCES07001(WES) MG G2MCES07001(WES) TF EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G2MCES07001KD EUDAMED
- Basic UDI-DI
- B-G2MCES07001KD EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER 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
Clinical Exome Sequencing (CES) Expanded 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-G2MCES07001KD | 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 (1)
- EUDAMED ea35953e-8f23-435e-9668-8149d28d7313 61 fields · synced Jun 18, 2026