Identity
- Trade Name
- CSF 16-well EUDAMED
- Device Name
- Step 2 Plates for CSF 16-well EUDAMEDStep 1 tubes for CSF 16-well EUDAMED
- Model / Reference
- 27050P EUDAMED27050S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044001949 EUDAMED09343044001956 EUDAMED
- Basic UDI-DI
- B-09343044001949 EUDAMEDB-09343044001956 EUDAMED
- EMDN Code
- W0105070505 MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX 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
CSF 16-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-09343044001949 | 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 cb0a63ab-5c0f-4be9-a57f-00f0c60325ac 61 fields · synced Jul 9, 2026
- EUDAMED b1eb1fd8-4069-4626-8f0d-ccce5a7cd5d8 61 fields · synced May 17, 2026