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CA72-4 CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB1407Model AutoLumo analyzerRef CMB1403Ref CMB1405
Identity
- Trade Name
- CA72-4 CLIA Microparticles EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDCMB1407 EUDAMEDCMB1403 EUDAMEDCMB1405 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359517119 EUDAMED06942359549394 EUDAMED06942359549417 EUDAMED
- Basic UDI-DI
- 697015090000015GV EUDAMED
- EMDN Code
- W0102030105 CANCER ANTIGEN 72-4 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
CA72-4 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 | 697015090000015GV | 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 bb0e144b-3123-483c-9708-e89f786bf403 61 fields · synced Jul 8, 2026
- EUDAMED a29283c2-e5b4-4894-b103-7fe6ba4cace5 61 fields · synced May 16, 2026
- EUDAMED 17ec2f3d-9867-44ac-8c66-00bd81d6dfae 61 fields · synced May 19, 2026