Identity
- Trade Name
- Quantia Ferritin Standard EUDAMED
- Device Name
- Quantia Ferritin EUDAMED
- Model / Reference
- 6K49-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00380740157463 EUDAMED
- Basic UDI-DI
- 8436003070115WS EUDAMED
- EMDN Code
- W0102070102 FERRITIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
Quantia Ferritin Standard by Biokit, S.a. — 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 | 8436003070115WS | Class B | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (1)
- EUDAMED 295fddb0-1d34-4cb4-99e9-61217a26080e 61 fields · synced Jun 20, 2026