Identity
- Trade Name
- HighPlex System EUDAMED
- Device Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated EUDAMED
- Model / Reference
- 91501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044002298 EUDAMED
- Basic UDI-DI
- 93430440W02039006V6 EUDAMED
- Direct Marketing DI
- 09343044002298 EUDAMED
- EMDN Code
- W02039006 DNA THERMAL CYCLERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
HighPlex System by AusDiagnostics Pty 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 | 93430440W02039006V6 | Class A | Active |
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Manufacturer
- Manufacturer
- AusDiagnostics Pty Ltd
- EUDAMED SRN
- AU-MF-000020558
- Authorised Representative
- R-Biopharm AG DE-AR-000050025
Sources (1)
- EUDAMED 15a20b17-a116-497f-84ea-0d55d278b06c 61 fields · synced Jun 18, 2026