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CA50 CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMB0405Model CA50 CLIA MicroparticlesRef CMB0403Ref CMB0410
Identity
- Trade Name
- CA50 CLIA Microparticles EUDAMED
- Model / Reference
- CA50 CLIA Microparticles EUDAMEDCMB0405 EUDAMEDCMB0403 EUDAMEDCMB0410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359549813 EUDAMED06942359549790 EUDAMED06942359508896 EUDAMED
- Basic UDI-DI
- 697015090000225HA EUDAMED
- EMDN Code
- W0102030104 CANCER ANTIGEN 50 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
CA50 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 | 697015090000225HA | 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 83406fa1-2f27-4e86-a3e3-0be862c10b21 61 fields · synced Jul 22, 2026
- EUDAMED 5efdd354-85d5-4dad-aa22-686341e7b0d7 61 fields · synced May 18, 2026
- EUDAMED e68f018f-4ec7-42d8-a873-2b06e5b501eb 61 fields · synced May 18, 2026