S100 CLIA Microparticles
by Autobio Diagnostics Co., Ltd. EUDAMED
Active
Ref CMB2305Model AutoLumo analyzer
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697015090000133H4 | Date13 Jan 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Model / Reference
- AutoLumo analyzer, CMB2305
- Primary DI / UDI-DI
- 06942359550611
- Basic UDI-DI
- 697015090000133H4
- EMDN Code
- W0102039012
- 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
Other properties (6)
- Sterile: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No