CA72-4 CLIA Microparticles
by Autobio Diagnostics Co., Ltd. China EUDAMED
Ref CMB1403Model AutoLumo analyzer
EMDN W0102030105
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697015090000015GV | Date14 Sep 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- AutoLumo analyzer, CMB1403
- Primary DI / UDI-DI
- 06942359549394
- Basic UDI-DI
- 697015090000015GV
- EMDN Code
- W0102030105 Cancer antigen 72-4
- Device Class
- Class C
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000003348
- Authorised representative
- QbD RepS BV BE-AR-000000040
Other devices from Autobio Diagnostics Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (6)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED a29283c2-e5b4-4894-b103-7fe6ba4cace5