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RIDA®Plex Respiratory Pathogens 16 well Step 2
EUDAMEDClass IVD General (EU MDR)
Ref 20620PRef 20612S
Identity
- Trade Name
- RIDA®Plex Respiratory Pathogens 16 well Step 2 EUDAMEDRIDA®Plex Respiratory Pathogens B 16 well EUDAMED
- Device Name
- RIDA®Plex Respiratory Pathogens 16 well EUDAMEDRIDA®Plex Respiratory Pathogens B 16 well Step 1 EUDAMED
- Model / Reference
- 20620P EUDAMED20612S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044006708 EUDAMED09343044006678 EUDAMED
- Basic UDI-DI
- B-09343044006708 EUDAMEDB-09343044006678 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass IVD Annex II List B EUDAMED
- Market of Registration
- Germany 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
RIDA®Plex Respiratory Pathogens 16 well Step 2 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-09343044006708 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- AusDiagnostics Pty Ltd
- EUDAMED SRN
- AU-MF-000020558
- Authorised Representative
- R-Biopharm AG DE-AR-000050025
Sources (2)
- EUDAMED 3b58b509-4ac1-41d6-887b-4926f038696f 61 fields · synced Jul 14, 2026
- EUDAMED ab33962a-97ef-4096-9a16-dca743d4de47 61 fields · synced Jul 14, 2026