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AmoyDx® AutoExtract Kit (FFPE DNA)
EUDAMEDClass A (EU MDR)
Ref 8.02.0147Model 48 tests/kit
Identity
- Trade Name
- AmoyDx® AutoExtract Kit (FFPE DNA) EUDAMED
- Device Name
- AmoyDx® AutoExtract Kit (FFPE DNA) EUDAMED
- Model / Reference
- 48 tests/kit EUDAMED8.02.0147 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959094214838 EUDAMED
- Basic UDI-DI
- 69590942A0036GM EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
New Device
No
EUDAMED
AmoyDx® AutoExtract Kit (FFPE DNA) by Amoy Diagnostics Co., LTD. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69590942A0036GM | Class A | 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 582abfa9-cb2f-4dd9-80aa-0192432fefd6 61 fields · synced Jun 18, 2026