Medical device registration
The hemodialysis information processing software developed by Daite Intelligent Technology holds a Class II medical device registration from the People's Republic of China.
Certificate details
- Registration number
- 沪械注准20252210297
- Registrant
- Daite Intelligent Technology (Shanghai) Co., Ltd.
- Device name
- Hemodialysis Information Processing Software
- Model
- 60110700001 · v1
- Structure and composition
- Standalone software, B/S architecture — client plus cloud server
- Registered scope
- For the transmission, display and processing of dialysis data in blood purification centers
- Issuing authority
- Shanghai Medical Products Administration
- Approved
- 2025-07-17
- Valid until
- 2030-07-16
The registration is valid until 16 July 2030. Significant changes to the software require a change registration.
How capabilities map to the registered scope
The registration covers the transmission, display and processing of dialysis data. To avoid any ambiguity, every capability is labelled with the regulatory tier it sits in.
Within registered scope
Ward rounds, laboratory evaluation, foot management, quality control, laboratory reminders, central monitoring display, bedside terminal display, and facility IoT.
Clinical decision support
AI-assisted drafting, attribution analysis, and reference suggestions. Suggestions are provided for reference and require clinician confirmation before any action.
In validation
Dry weight prediction, heart failure risk assessment, intradialytic hypotension early warning, and the four real-time monitoring algorithms. These are research programmes, not offered as registered clinical functions and not for clinical use.