AutoLumo CA72-4 Calibrators
by Autobio Diagnostics Co., Ltd. China EUDAMED
Ref CA060203Model AutoLumo analyzer
EMDN W0102152205
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, CA060203
- Primary DI / UDI-DI
- 06942359505246
- Basic UDI-DI
- 697015090000015GV
- EMDN Code
- W0102152205 Tumour marker standards and calibrators
- 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 (7)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (1)
- EUDAMED 12d9cb45-1f9f-459a-9343-9d66cbf14cc6