← Back to catalogue
Synthetic Positive Controls for STIs and Herpes
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 91021
Identity
- Trade Name
- Synthetic Positive Controls for STIs and Herpes EUDAMED
- Device Name
- Synthetic Positive Controls for STIs and Herpes EUDAMED
- Model / Reference
- 91021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044006227 EUDAMED
- Basic UDI-DI
- B-09343044006227 EUDAMED
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Italy EUDAMEDGermany 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
Synthetic Positive Controls for STIs and Herpes by AusDiagnostics Pty Ltd — Class IVD Annex II List B — 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-09343044006227 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AusDiagnostics Pty Ltd
- EUDAMED SRN
- AU-MF-000020558
- Authorised Representative
- R-Biopharm AG DE-AR-000050025
Sources (2)
- EUDAMED 90d925d1-3985-446e-b442-55432fdbe442 61 fields · synced Jul 9, 2026
- EUDAMED 8cdf53bf-676e-4679-b44a-a257a3d2ad46 61 fields · synced Jun 18, 2026