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Alinity c Ferritin/Myoglobin/IgE Control Kit
EUDAMEDClass IVD General (EU MDR)
Ref 04R4610Ref 04R4616
by Biokit S.A.
Identity
- Trade Name
- Alinity c Ferritin/Myoglobin/IgE Control Kit EUDAMED
- Device Name
- Alinity c Ferritin/Myoglobin/IgE Control Kit EUDAMED
- Model / Reference
- 04R4610 EUDAMED04R4616 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-04R46108K EUDAMED00380740175443 EUDAMED
- Basic UDI-DI
- B-04R46108K EUDAMED8436003070641XL EUDAMED
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass C EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Alinity c Ferritin/Myoglobin/IgE Control Kit by Biokit, S.a. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-04R46108K | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-04R46108K | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biokit S.A.
- EUDAMED SRN
- ES-MF-000002406
Sources (2)
- EUDAMED 17bf1c4c-009a-4d5c-8feb-2061ed37d871 61 fields · synced Jul 31, 2026
- EUDAMED bdd4f45d-a5c4-49c8-8593-39cfb937c13d 61 fields · synced May 18, 2026