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Real-time fluorescence quantitative PCR analyzer
EUDAMEDClass A (EU MDR)
Ref MQ96-X4
Identity
- Trade Name
- Real-time fluorescence quantitative PCR analyzer EUDAMED
- Device Name
- Real-time fluorescence quantitative PCR analyzer EUDAMED
- Model / Reference
- MQ96-X4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976045290024 EUDAMED
- Basic UDI-DI
- 697604529MQ96-X4QM EUDAMED
- Direct Marketing DI
- 06976045290024 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
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
Real-time fluorescence quantitative PCR analyzer by Chongqing ME Instruments Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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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 | 697604529MQ96-X4QM | Class A | Active |
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Manufacturer
- Manufacturer
- Chongqing ME Instruments Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035349
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED c35f10c1-41e5-447e-8f55-5cfc68f4c8e9 61 fields · synced Jul 15, 2026