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QIAstat-Dx Analytical Module
EUDAMEDClass A (EU MDR)
Ref 9002814Model QIAstat-Dx Analyzer
by QIAGEN GmbH
Identity
- Trade Name
- QIAstat-Dx Analytical Module EUDAMED
- Device Name
- QIAstat-Dx Analyzer 1.0; QIAstat-Dx Analyzer 2.0 EUDAMED
- Model / Reference
- QIAstat-Dx Analyzer EUDAMED9002814 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053228033929 EUDAMED
- Basic UDI-DI
- 4053228IQSTA00000000001VT EUDAMED
- Direct Marketing DI
- 04053228033929 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS 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
Category: Nucleic acid sample preparation instrument IVD
QIAstat-Dx Analytical Module by QIAGEN GmbH — 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 | 4053228IQSTA00000000001VT | Class A | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
- EUDAMED SRN
- DE-MF-000004949
Sources (1)
- EUDAMED 8810e1bc-8409-4dea-894f-37ab59d7ce75 61 fields · synced Jun 19, 2026