AutoChem B861
by Autobio Labtec Instruments Co., Ltd. China EUDAMED
Ref 10023Model AutoChem B861(With ISE Module) AutoChem B861(Without ISE Module)
EMDN W0201010107
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697304909Model001FF | Date27 Aug 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Automatic Chemistry Analyzer
- Model / Reference
- AutoChem B861(With ISE Module) AutoChem B861(Without ISE Module), 10023
- Primary DI / UDI-DI
- 06973049096959
- Basic UDI-DI
- 697304909Model001FF
- EMDN Code
- W0201010107 CHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (with ISE mode test/h > 800 and <= 1.200)
- Device Class
- Class A
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000012110
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Autobio Labtec Instruments Co., Ltd.
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
Sources (1)
- EUDAMED 9dd7668e-e380-4b9f-99f2-dc8ad0efd71f