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CA125 CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB0605Model AutoLumo analyzerRef CMB0607Ref CMB0604Ref CMB0608
Identity
- Trade Name
- CA125 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB0605 EUDAMEDCMB0607 EUDAMEDCMB0604 EUDAMEDCMB0608 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359548717 EUDAMED06970150905347 EUDAMED06942359516761 EUDAMED06970150905330 EUDAMED06942359516778 EUDAMED
- Basic UDI-DI
- 697015090000008GY EUDAMED
- EMDN Code
- W0102030106 CANCER ANTIGEN 125 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
CA125 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 | 697015090000008GY | 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 (5)
- EUDAMED 492f6c24-870f-4e29-8bb7-e388b4b10644 61 fields · synced Jul 31, 2026
- EUDAMED 735fab38-b3e4-4162-b0e0-04e87287a46b 61 fields · synced May 17, 2026
- EUDAMED c7b86472-2e8c-4c65-bda6-4cd52bb31678 61 fields · synced May 17, 2026
- EUDAMED 10bd1f1b-4a9a-4cd5-9852-56a0b83f39b9 61 fields · synced May 18, 2026
- EUDAMED a2dea903-1ec4-44ca-89bd-eb3578d6385b 61 fields · synced May 19, 2026