Identity
- Trade Name
- PCR Nucleic Acid Analyzer EUDAMED
- Device Name
- PCR Nucleic Acid Analyzer EUDAMED
- Model / Reference
- SWM-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974900600018 EUDAMED
- Basic UDI-DI
- 697490060SWM-01P8 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
Category: Nucleic acid sample preparation instrument IVD
PCR Nucleic Acid Analyzer by Zhuhai Shineway Biotech Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697490060SWM-01P8 | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai Shineway Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000027278
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 9a038a49-3eb9-4c03-a3b9-1107bc32687e 61 fields · synced Jul 9, 2026