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Real-Time Fluorescence Quantitative PCR system
EUDAMEDClass A (EU MDR)
Ref QuantReady K9600
Identity
- Device Name
- Real-Time Fluorescence Quantitative PCR system EUDAMED
- Model / Reference
- QuantReady K9600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975461700377 EUDAMED
- Basic UDI-DI
- 697546170QuantReadyKZ EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS 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
Real-Time Fluorescence Quantitative PCR system by Hangzhou Lifereal Biotechnology 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 | 697546170QuantReadyKZ | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Lifereal Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019191
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 685e90aa-03e6-4306-8427-2d8b0376ba7b 61 fields · synced Jun 18, 2026