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ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument
EUDAMEDClass A (EU MDR)
Ref NGX16-4F
Identity
- Trade Name
- ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument EUDAMED
- Device Name
- Real-Time Fluorescence Quantitative PCR Instrument EUDAMED
- Model / Reference
- NGX16-4F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595039373 EUDAMED
- Basic UDI-DI
- 868459503NGX164FYT EUDAMED
- EMDN Code
- W02050199 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
ChainPro™ Real-Time Fluorescence Quantitative PCR Instrument by Vitrosens Biotechnology Inc. — 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 | 868459503NGX164FYT | Class A | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 7b7717bb-d442-4b61-85e1-5ee6c5ca2a66 61 fields · synced Oct 6, 2026