Identity
- Trade Name
- Ferritin EUDAMEDFerritin Control EUDAMED
- Device Name
- Ferritin EUDAMEDFerritin Control EUDAMED
- Model / Reference
- 981949 EUDAMED981875 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153004094 EUDAMED16438153000805 EUDAMED
- Basic UDI-DI
- 6438153BU00125BN EUDAMED6438153BU00122BG EUDAMEDB-16438153000805 EUDAMED
- Direct Marketing DI
- 16438153004094 EUDAMED16438153000805 EUDAMED
- EMDN Code
- W0102070102 FERRITIN EUDAMEDW0102152006 ANAEMIA RELATED/VITAMIN CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
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
No
EUDAMED
Ferritin by Thermo Fisher Scientific Oy — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 6438153BU00125BN | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 6438153BU00125BN | Class B | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (3)
- EUDAMED 52a293a0-fff3-4b86-98b4-917f7df7a4ac 61 fields · synced Oct 6, 2026
- EUDAMED f9405084-2e98-4a11-8bcf-b40e6cb1379d 61 fields · synced May 17, 2026
- EUDAMED 4dbf245b-bc16-4f3e-b85c-cd11fe650d19 61 fields · synced May 18, 2026