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AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref 8.01.0026Model 8 tests/kit
Identity
- Device Name
- AmoyDx® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit EUDAMED
- Model / Reference
- 8 tests/kit EUDAMED8.01.0026 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959094210915 EUDAMED
- Basic UDI-DI
- B-06959094210915 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® ALK Gene Fusions and ROS1 Gene Fusions Detection Kit by Amoy Diagnostics 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-06959094210915 | 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 (1)
- EUDAMED 1f9a5e4b-9cbf-401f-aa7c-5991233a7bd7 61 fields · synced Jun 17, 2026