Auto Chemistry Analyzer
by E-LAB Biological Science & Technology Co., Ltd. China EUDAMED
Ref ES-400Model AS-800, AS-600, AS-480, AS-450, AS-380, AS-350, AS-280, AS-240,AS-160, AS-120, ES-480, ES-400, ES-380, ES-320, ES-200
EMDN W0201010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697517840001LX75 | Date12 Oct 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- AS-800, AS-600, AS-480, AS-450, AS-380, AS-350, AS-280, AS-240, AS-160, AS-120, ES-480, ES-400, ES-380, ES-320, ES-200
- Primary DI / UDI-DI
- 06975178400133
- Basic UDI-DI
- 697517840001LX75
- EMDN Code
- W0201010101 CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
- Device Class
- Class A
- Market of Registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000020119
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Other devices from E-LAB Biological Science & Technology Co., Ltd.
See all devices from E-LAB Biological Science & Technology Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 06975178400133|697517840001LX75