Real-time PCR Nucleic Acid Detection System
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- Real-time PCR Nucleic Acid Detection System EUDAMEDShineway FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- Real-time PCR Nucleic Acid Detection System EUDAMED
- Model / Reference
- SWM-02 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 16974900600039 EUDAMEDFDA UDI
- Basic UDI-DI
- 697490060SWM-02PA EUDAMED
- Direct Marketing DI
- 16974900600039 EUDAMED
- FDA Product Code
- OOI FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Nucleic acid sample preparation instrument IVD
Real-time PCR Nucleic Acid Detection System by Zhuhai Shineway Biotech Co., Ltd — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697490060SWM-02PA | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (2)
- EUDAMED 8eaa5594-fae3-4db5-9728-d858d1645030 61 fields · synced Jul 9, 2026
- FDA UDI c6a63b39-c204-4e1e-93ff-01a98806453c 32 fields · synced May 30, 2026