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Ferritin CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB0905Model AutoLumo analyzerRef CMB0902Ref CMB0903
Identity
- Trade Name
- Ferritin CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB0905 EUDAMEDCMB0902 EUDAMEDCMB0903 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359549011 EUDAMED06970150908355 EUDAMED06942359548991 EUDAMED
- Basic UDI-DI
- 697015090000011GM EUDAMED
- EMDN Code
- W0102070102 FERRITIN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Yes
EUDAMEDEUDAMED
Ferritin CLIA Microparticles by Autobio Diagnostics Co., Ltd. — Class C — 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 | 697015090000011GM | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED 12187b27-4367-42b2-a547-364d3e37938d 61 fields · synced Aug 4, 2026
- EUDAMED b6240f69-27a2-4cc3-ab59-ea0d69649ebf 61 fields · synced May 17, 2026
- EUDAMED f6a9df5b-a4f9-4b7e-bc46-46d816afd498 61 fields · synced May 17, 2026