Identity
- Device Name
- Real-Time qPCR System EUDAMED
- Model / Reference
- SimpiDx Q16S EUDAMEDSimpiDx Q16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04899959024528 EUDAMED04899959024511 EUDAMED
- Basic UDI-DI
- 489995902451SL EUDAMED
- Direct Marketing DI
- 04899959024528 EUDAMED04899959024511 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 qPCR System by Quantidx Hong Kong Limited — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 489995902451SL | Class A | Active |
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Manufacturer
- Manufacturer
- Quantidx Hong Kong Limited
- EUDAMED SRN
- HK-MF-000023647
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED ec192508-d25d-476b-9ef0-b4a008642e90 61 fields · synced Jul 15, 2026
- EUDAMED 400b1b58-3bdc-4567-b5e2-f317297d3d09 61 fields · synced May 17, 2026