Identity
- Trade Name
- CRE EU 16-well EUDAMED
- Device Name
- Step 2 Plates for CRE EU 16-well EUDAMEDStep 1 tubes for CRE EU 16-well EUDAMED
- Model / Reference
- 21099P EUDAMED21099S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044002649 EUDAMED09343044002656 EUDAMED
- Basic UDI-DI
- B-09343044002649 EUDAMEDB-09343044002656 EUDAMED
- EMDN Code
- W0104080605,W0104080606 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
CRE EU 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-09343044002649 | 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 f1439582-bf59-4d49-a51f-82f11c1da8bf 61 fields · synced Jul 17, 2026
- EUDAMED 4f0d2708-d06a-4c76-8220-e55c5c961c6f 61 fields · synced May 19, 2026