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Real-time PCR Nucleic Acid Detection System
EUDAMEDClass A (EU MDR)
Ref MC42-P01
Identity
- Device Name
- Real-time PCR Nucleic Acid Detection System EUDAMED
- Model / Reference
- MC42-P01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974900600183 EUDAMED
- Basic UDI-DI
- 697490060MC42-P01GV 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
Real-time PCR Nucleic Acid Detection System by Zhuhai Shineway Biotech 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 | 697490060MC42-P01GV | 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 dd82fccd-4650-4a97-a9c4-afd2ddeb5afe 61 fields · synced Jun 19, 2026