Identity
- Trade Name
- Rotor-Gene Q MDx 5Plex HRM EUDAMED
- Device Name
- Rotor-Gene Q MDx EUDAMED
- Model / Reference
- 9002030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04053228022084 EUDAMED
- Basic UDI-DI
- 4053228IRGQ000000000001QQ EUDAMED
- Direct Marketing DI
- 04053228022084 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
Rotor-Gene Q MDx 5Plex HRM 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 | 4053228IRGQ000000000001QQ | Class A | Active |
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Manufacturer
- Manufacturer
- QIAGEN GmbH
- EUDAMED SRN
- DE-MF-000004949
Sources (1)
- EUDAMED 72925b39-0282-4c84-9bf0-0fbfbdc993ef 61 fields · synced Jun 18, 2026