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CEA CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB0201Model AutoLumo analyzerRef CMB0202Ref CMB0203
Identity
- Trade Name
- CEA CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB0201 EUDAMEDCMB0202 EUDAMEDCMB0203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150905231 EUDAMED06970150908287 EUDAMED06942359548595 EUDAMED
- Basic UDI-DI
- 697015090000007GW EUDAMED
- EMDN Code
- W0102030112 CARCINOEMBRYONIC ANTIGEN 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
CEA 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 | 697015090000007GW | 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 4e4eeda5-a136-49bb-a95a-74d70f46c10b 61 fields · synced Sep 17, 2026
- EUDAMED c75af89b-67d2-417b-963b-934c126a4574 61 fields · synced May 17, 2026
- EUDAMED 43a301ba-45fa-4684-88c1-723a3d3dc9f0 61 fields · synced May 18, 2026