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CA15-3 CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB0705Model AutoLumo analyzerRef CMB0702
Identity
- Trade Name
- CA15-3 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB0705 EUDAMEDCMB0702 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359549318 EUDAMED06970150908331 EUDAMED
- Basic UDI-DI
- 697015090000009H2 EUDAMED
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 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
CA15-3 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 | 697015090000009H2 | 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 (2)
- EUDAMED 6aa3af42-ac91-4fac-b730-08ea82986efe 61 fields · synced Jul 13, 2026
- EUDAMED 2ad30e18-9af4-46a9-9e96-3e13dc93be96 61 fields · synced May 18, 2026