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AmoyDx® AutoExtract Kit (FFPE DNA/RNA)
EUDAMEDClass A (EU MDR)
Ref 8.02.0145Model AmoyDx Nucleic Acid Extraction SystemModel 24 tests/kit
Identity
- Trade Name
- AmoyDx® AutoExtract Kit (FFPE DNA/RNA) EUDAMED
- Device Name
- AmoyDx® AutoExtract Kit (FFPE DNA/RNA) EUDAMED
- Model / Reference
- AmoyDx Nucleic Acid Extraction System EUDAMED8.02.0145 EUDAMED24 tests/kit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959094214692 EUDAMED
- Basic UDI-DI
- 69590942A0035GK EUDAMED
- EMDN Code
- W050299 DEVICES FOR SAMPLES TRANSPORT - 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
Yes
EUDAMEDEUDAMED
AmoyDx® AutoExtract Kit (FFPE DNA/RNA) 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 | 69590942A0035GK | 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 (2)
- EUDAMED 8f6fc5b0-05ff-4281-ae51-9b856a92cb5a 61 fields · synced Jul 8, 2026
- EUDAMED c72b2579-7c31-42b6-883e-3e65a3883ae2 61 fields · synced Jun 18, 2026