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CA242 CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB1705Model AutoLumo analyzerRef CMB1702Ref CMB1707Ref CMB1703
Identity
- Trade Name
- CA242 CLIA Microparticles EUDAMEDCA242 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB1705 EUDAMEDCMB1702 EUDAMEDCMB1707 EUDAMEDCMB1703 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359549516 EUDAMED06970150908430 EUDAMED06942359517164 EUDAMED06942359549493 EUDAMED
- Basic UDI-DI
- 697015090000016GX EUDAMED
- EMDN Code
- W0102030108 CANCER ANTIGEN 242 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
CA242 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 | 697015090000016GX | 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 370c5687-489f-4813-8dde-4c29a26e1dc0 61 fields · synced Jul 23, 2026
- EUDAMED ef0b92a8-ead6-4c02-8e6a-e9f1e65537aa 61 fields · synced May 17, 2026
- EUDAMED 8490d571-2f63-4286-af5a-36390e4ce2f1 61 fields · synced May 18, 2026
- EUDAMED f9f49269-1668-4639-a2a3-034176d29294 61 fields · synced May 18, 2026