Identity
- Trade Name
- Automatic Nucleic Acid System EUDAMED
- Device Name
- Automatic Nucleic Acid System EUDAMED
- Model / Reference
- NFast 9601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974561521318 EUDAMED
- Basic UDI-DI
- 697456152NFast9600TG EUDAMED
- Direct Marketing DI
- 06974561521318 EUDAMED
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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 System by Shenzhen Uni-medica 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 | 697456152NFast9600TG | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Uni-medica Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000022946
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 20325ffc-075d-464b-aaab-0aa41a0d2922 61 fields · synced Jun 19, 2026