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BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing)
EUDAMEDClass IVD General (EU MDR)
Ref L000043Model 96 tests/kit
Identity
- Trade Name
- BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing) EUDAMED
- Device Name
- BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing) EUDAMED
- Model / Reference
- 96 tests/kit EUDAMEDL000043 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974968583162 EUDAMED
- Basic UDI-DI
- B-06974968583162 EUDAMED
- EMDN Code
- W01060203 BRCA 1+2 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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
BRCA1 and BRCA2 Gene Mutation Detection Kit ( Reversible Terminator Sequencing) by GeneMind Biosciences Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06974968583162 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- GeneMind Biosciences Co., Ltd.
- EUDAMED SRN
- CN-MF-000025785
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 2db2617d-b18c-4343-b0d1-b95ce991668e 61 fields · synced Jun 19, 2026