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Automatic Nucleic Acid Extraction System
EUDAMEDClass A (EU MDR)
Ref CY-12Model CY-10, CY-11, CY-12
Identity
- Trade Name
- Automatic Nucleic Acid Extraction System EUDAMED
- Device Name
- Automatic Nucleic Acid Extraction System EUDAMED
- Model / Reference
- CY-10, CY-11, CY-12 EUDAMEDCY-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974488992079 EUDAMED
- Basic UDI-DI
- 697448899CY-A1/3/8/2/8V73 EUDAMED
- Direct Marketing DI
- 06974488992079 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Automatic Nucleic Acid Extraction System by Huachenyang (Shenzhen) Technology 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 | 697448899CY-A1/3/8/2/8V73 | Class A | Active |
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Manufacturer
- Manufacturer
- Huachenyang (Shenzhen) Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000020236
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 41f40ee3-b13e-4d5d-a003-e25d0ed2365d 61 fields · synced Jun 19, 2026