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Staphylococcus + VRE 8-well
EUDAMEDClass IVD General (EU MDR)
Ref 21340PRef 21340S
Identity
- Trade Name
- Staphylococcus + VRE 8-well EUDAMED
- Device Name
- Step 2 Plates for Staphylococcus + VRE 8-well EUDAMEDStep 1 tubes for Staphylococcus + VRE 8-well EUDAMED
- Model / Reference
- 21340P EUDAMED21340S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044002021 EUDAMED09343044002038 EUDAMED
- Basic UDI-DI
- B-09343044002021 EUDAMEDB-09343044002038 EUDAMED
- EMDN Code
- W0105070502 OTHER MULTIPLE INFECTIOUS - 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
Staphylococcus + VRE 8-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-09343044002021 | 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 b17fc2ff-9a55-4ea7-b197-0581c30cd079 61 fields · synced Jul 26, 2026
- EUDAMED c3168faa-92a9-4deb-ab21-f10090a30daa 61 fields · synced May 17, 2026