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AmoyDx Nucleic Acid Extraction System
EUDAMEDClass A (EU MDR)
Ref 8.18.0013Model EASY12
Identity
- Trade Name
- AmoyDx Nucleic Acid Extraction System EUDAMED
- Device Name
- AmoyDx Nucleic Acid Extraction System EUDAMED
- Model / Reference
- EASY12 EUDAMED8.18.0013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959094214463 EUDAMED
- Basic UDI-DI
- 69590942A0033GF EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
AmoyDx Nucleic Acid Extraction System 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 | 69590942A0033GF | 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 07d0c3b5-3202-4cf2-987c-dac24be125fa 61 fields · synced Jul 12, 2026