Identity
- Trade Name
- CRE 16-well EUDAMEDRIDA®Plex CRE 16 well Step 1 EUDAMED
- Device Name
- Step 2 Plates for CRE 16-well EUDAMEDRIDA®Plex CRE 16 well EUDAMED
- Model / Reference
- 21098P EUDAMED21098S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044002199 EUDAMED09343044006449 EUDAMED
- Basic UDI-DI
- B-09343044002199 EUDAMEDB-09343044006449 EUDAMED
- EMDN Code
- W0104080605,W0104080606 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Malta 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
CRE 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-09343044002199 | Class IVD General | 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
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED a37d5ba1-d225-4ec0-a09e-3d3546a6531a 61 fields · synced Jul 16, 2026
- EUDAMED e50554f1-19fe-4636-9838-81e07e843997 61 fields · synced May 16, 2026