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Ferritin
EUDAMEDClass IVD General (EU MDR)
Ref 12600788Model Ferritin Quantitative Test Kit (Fluorescence Immunochromatography)
Identity
- Trade Name
- Ferritin EUDAMED
- Device Name
- Ferritin Quantitative Test Kit (Fluorescence Immunochromatography) EUDAMED
- Model / Reference
- Ferritin Quantitative Test Kit (Fluorescence Immunochromatography) EUDAMED12600788 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-06934175046317QE EUDAMED
- Basic UDI-DI
- B-06934175046317QE EUDAMED
- EMDN Code
- W0102070102 FERRITIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Ferritin by Changsha Sinocare Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06934175046317QE | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Changsha Sinocare Inc.
- EUDAMED SRN
- CN-MF-000012244
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 002d3aaa-ea81-4d03-8c6d-067ebbba2672 61 fields · synced Jul 23, 2026