Intelligent Total Laboratory Automation System, Model: iTLA MAX
by Shenzhen Yhlo Biotech Co., Ltd. FDA registration: China EUDAMED
Ref LX0248Model iTLA Max EMDN W02060101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number692591270286HX | Date11 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Intelligent Total Laboratory Automation
- Model / Reference
- iTLA Max, LX0248
- Primary DI / UDI-DI
- 06925912735434
- Basic UDI-DI
- 692591270286HX
- EMDN Code
- W02060101 Automated systems for the management of pre and post-analysis
- Device Class
- Class A
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000001137
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Yhlo Biotech 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 06925912735434|692591270286HX