Identity
- Trade Name
- 96-well solid phase extraction plate EUDAMED
- Device Name
- Accessories for Hepcidin-25 LC-MS/MS EUDAMED
- Model / Reference
- KM400096SPE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598011977 EUDAMED
- Basic UDI-DI
- 4050598LCACFELX EUDAMED
- Direct Marketing DI
- 04050598011977 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
New Device
Yes
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
96-well solid phase extraction plate by Immundiagnostik AG — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 4050598LCACFELX | Class A | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED d00f8faa-eb72-46e8-9d0b-5ab557929863 61 fields · synced Jul 30, 2026