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CA19-9 CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB0807Model AutoLumo analyzerRef CMB0805Ref CMB0802
Identity
- Trade Name
- CA19-9 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB0807 EUDAMEDCMB0805 EUDAMEDCMB0802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359516860 EUDAMED06942359549615 EUDAMED06970150908348 EUDAMED
- Basic UDI-DI
- 697015090000010GK EUDAMED
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 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
CA19-9 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 | 697015090000010GK | 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 0633b879-2e19-43ab-a9dd-2add3b1c27c7 61 fields · synced Jul 28, 2026
- EUDAMED 1001d01d-ed49-4e88-a598-5bc4ccb2dd74 61 fields · synced May 17, 2026
- EUDAMED 06e43175-bd7d-48d5-9338-09fd023d2432 61 fields · synced May 18, 2026