Identity
- Trade Name
- Haemochromatosis 8-well EUDAMED
- Device Name
- Step 1 Tubes for Haemochromatosis 8-well EUDAMEDStep 2 Plates for Haemochromatosis 8-well EUDAMED
- Model / Reference
- 23156S EUDAMED23156P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09343044002335 EUDAMED09343044002328 EUDAMED
- Basic UDI-DI
- B-09343044002335 EUDAMEDB-09343044002328 EUDAMED
- EMDN Code
- W0106010105 HAEMOCHROMATOSIS 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
Haemochromatosis 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-09343044002335 | 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 6d77725e-8c60-4e13-8803-c2f0a295ac98 61 fields · synced Aug 4, 2026
- EUDAMED f053cdaa-48a6-4409-b4f4-e63d9dc77ea6 61 fields · synced May 18, 2026