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AFP CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB0101Model AutoLumo analyzerRef CMB0103Ref CMB0102Ref CMB0105
Identity
- Trade Name
- AFP CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB0101 EUDAMEDCMB0103 EUDAMEDCMB0102 EUDAMEDCMB0105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150905194 EUDAMED06942359548892 EUDAMED06970150908270 EUDAMED06942359548915 EUDAMED
- Basic UDI-DI
- 697015090000006GU EUDAMED
- EMDN Code
- W0102039001 ALPHAFETOPROTEIN 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
No
EUDAMEDEUDAMED
AFP 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 | 697015090000006GU | 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 (4)
- EUDAMED 0de765a0-a99b-4e4e-8162-d2142c340b5e 61 fields · synced Jul 29, 2026
- EUDAMED a1025ed0-d978-4efe-bd7c-aa91aa47bc55 61 fields · synced May 18, 2026
- EUDAMED 4f3fa707-14cc-4564-aa41-78c97196c753 61 fields · synced May 18, 2026
- EUDAMED 52c3bc8e-fa12-4a2e-9698-5f0b1f6393a6 61 fields · synced May 18, 2026