Identity
- Trade Name
- Hepcidin-25 LC-MS/MS Kit EUDAMED
- Device Name
- iron metabolism EUDAMED
- Model / Reference
- KM4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598001374 EUDAMED
- Basic UDI-DI
- 4050598CMFEXA EUDAMED
- Direct Marketing DI
- 04050598001374 EUDAMED
- EMDN Code
- W01010299 SUBSTRATES - OTHER EUDAMED
Classification
- Device Class
- Class 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Hepcidin-25 LC-MS/MS Kit by Immundiagnostik AG — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4050598CMFEXA | Class B | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED 769de012-f8f8-4d71-9691-b12ae2fea212 61 fields · synced Jul 9, 2026