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High Risk HPV Genotyping 8-well
EUDAMEDClass IVD General (EU MDR)
Ref 23201PRef 23201S
Identity
- Trade Name
- High Risk HPV Genotyping 8-well EUDAMED
- Device Name
- Step 2 Plates for High Risk HPV Genotyping 8-well EUDAMEDStep 1 tubes for High Risk HPV Genotyping 8-well EUDAMED
- Model / Reference
- 23201P EUDAMED23201S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044002427 EUDAMED09343044002434 EUDAMED
- Basic UDI-DI
- B-09343044002427 EUDAMEDB-09343044002434 EUDAMED
- EMDN Code
- W0105041003 PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
High Risk HPV Genotyping 8-well by AusDiagnostics Pty Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-09343044002427 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- AusDiagnostics Pty Ltd
- EUDAMED SRN
- AU-MF-000020558
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 14d5f491-58c0-4c7b-9cb4-fa971bb424f4 61 fields · synced Jul 30, 2026
- EUDAMED 891b0486-d426-4aa9-9509-cef9ae9a3381 61 fields · synced May 18, 2026