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Respiratory Pathogens 16-well
EUDAMEDClass IVD General (EU MDR)
Ref 20620SRef 20620P
Identity
- Trade Name
- Respiratory Pathogens 16-well EUDAMED
- Device Name
- Step 1 tubes for Respiratory Pathogens 16-well EUDAMEDStep 2 Plates for Respiratory Pathogens 16-well EUDAMED
- Model / Reference
- 20620S EUDAMED20620P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044004186 EUDAMED09343044004179 EUDAMED
- Basic UDI-DI
- B-09343044004186 EUDAMEDB-09343044004179 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT 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
Respiratory Pathogens 16-well by AusDiagnostics Pty Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Respiratory Pathogens
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-09343044004186 | 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 14dfc2b2-5add-4dff-b186-9da5a193a0ec 61 fields · synced Jul 11, 2026
- EUDAMED 7278a995-d621-4207-91e7-02d1bd36eb50 61 fields · synced May 19, 2026