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Synthetic Positive Controls for CSF
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 91081
Identity
- Trade Name
- Synthetic Positive Controls for CSF EUDAMED
- Device Name
- Synthetic Positive Controls for CSF EUDAMED
- Model / Reference
- 91081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044002090 EUDAMED
- Basic UDI-DI
- B-09343044002090 EUDAMED
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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
Synthetic Positive Controls for CSF 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-09343044002090 | Class IVD Annex II List B | 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 3f1625d7-04b3-4fb6-950d-b5ef31254ba3 61 fields · synced Jul 14, 2026