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AmoyDx® KRAS/NRAS Mutations Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref 8.01.0031Model 6 tests/kitRef 8.01.0032
Identity
- Device Name
- AmoyDx® KRAS/NRAS Mutations Detection Kit EUDAMED
- Model / Reference
- 6 tests/kit EUDAMED8.01.0031 EUDAMED8.01.0032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959094210885 EUDAMED06959094210892 EUDAMED
- Basic UDI-DI
- B-06959094210885 EUDAMEDB-06959094210892 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Northern Ireland 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
AmoyDx® KRAS/NRAS Mutations Detection Kit by Amoy Diagnostics 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-06959094210885 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Amoy Diagnostics Co., LTD.
- EUDAMED SRN
- CN-MF-000021843
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 9c4d35e4-9f0b-4230-9565-8a89b0262d64 61 fields · synced Jul 11, 2026
- EUDAMED cd6f3b8f-e5ee-46fc-97fa-3296934ce518 61 fields · synced May 18, 2026