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OncoScreen™ Focus CDx Tissue Kit
EUDAMEDClass IVD General (EU MDR)
Ref BRA-LC00202Ref BRA-LC00201
Identity
- Device Name
- OncoScreen™ Focus CDx Tissue Kit EUDAMED
- Model / Reference
- BRA-LC00202 EUDAMEDBRA-LC00201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974927490289 EUDAMED06974927490272 EUDAMED
- Basic UDI-DI
- B-06974927490289 EUDAMEDB-06974927490272 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
OncoScreen™ Focus CDx Tissue Kit by Guangzhou Burning Rock Dx Co., Ltd. — 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-06974927490289 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Guangzhou Burning Rock Dx Co., Ltd.
- EUDAMED SRN
- CN-MF-000041391
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 27194432-a443-41f3-8676-6e69632b83e8 61 fields · synced Jul 25, 2026
- EUDAMED 4aeecb7b-b2e8-468c-9f42-eb9fd3618734 61 fields · synced May 17, 2026