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Hand-held Nucleic Acid Detection Analyzer
EUDAMEDClass A (EU MDR)
Ref SWSI-05Model SWSI-02Ref SWAI-01Ref SWSI-03Ref SWSI-04
Identity
- Trade Name
- Hand-held Nucleic Acid Detection Analyzer EUDAMED
- Device Name
- Hand-held Nucleic Acid Detection Analyzer EUDAMED
- Model / Reference
- SWSI-02 EUDAMEDSWSI-05 EUDAMEDSWAI-01 EUDAMEDSWSI-03 EUDAMEDSWSI-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974900600145 EUDAMED16974900600114 EUDAMED16974900600121 EUDAMED16974900600138 EUDAMED
- Basic UDI-DI
- 697490060SWSI-0243 EUDAMED
- Secondary DI
- 26974900600111 EUDAMED
- Direct Marketing DI
- 16974900600145 EUDAMED16974900600114 EUDAMED16974900600121 EUDAMED16974900600138 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
Hand-held Nucleic Acid Detection 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 | 697490060SWSI-0243 | 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 (4)
- EUDAMED d1a763a9-55a3-49fc-b266-f40975fd106f 61 fields · synced Jul 17, 2026
- EUDAMED 45bb67bd-12ad-41e0-bc86-2259fad1dfe7 61 fields · synced May 17, 2026
- EUDAMED 8538d884-287a-4a70-a717-af06a3333115 61 fields · synced May 18, 2026
- EUDAMED ce924796-017a-4a15-9397-983246451dac 61 fields · synced May 18, 2026