Visionary Intelligence Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000018621
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- Shanghai International Holding Corp. GmbH(Europe)DE
What Visionary Intelligence Ltd. makes
Visionary Intelligence Ltd. manufactures software for fundus image analysis, pathological detection, disease classification, and patient image management, including systems such as EyeWisdom, Sugar Net, Eye Multipathic, Eye Reading Centre, Eye-PACS, Proximity Control, and Slowness Data Management. The company also produces hardware devices, specifically the Portable Free Eye-Seed Camera RC 350 series and the Visual Screening VS 550 series.
The company is based in China, and its portfolio consists of Class I and Class IIa medical devices. These products are listed in the EUDAMED database.
Catalogue
- Regimes: CE MDR Registry: EUDAMED
EyeWisdom Ref 09
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000018621
- EUDAMED status
- Active
- EUDAMED registered name
- Visionary Intelligence Ltd.
- Registered address
- Room1001-13, Floor 10, Building 9, No.35 Huayuan North Road,Haidian District, Beijing, P.R. China, 100083, Beijing, China
- Website
- www.vistel.cn
- [email protected]
- Phone
- +86-10-62643980
- PRRC contact
- Huihui Zheng
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 7 Sep 2028
SGS Belgium NV 1639 1 certificate
- CN23/00004797 Active
Quality management system EU MDR
- Issued
- 27 Feb 2025
- Expires
- 7 Sep 2028
- Reason
- Mnf data change
From the company website
Through in-depth learning and image analysis, our products enable eye images to undergo pathological detection and disease classification, assist doctors in faster and more accurate diagnosis of diseases, and digitize and manage patient images. The company’s software products are: the Sugar Net Aide-Aided Diagnostic System, the Eye Multipathic Aide-Aid Diagnostic System, the Eye Reading Centre, the Eye-PACS System, the Proximity Control System, the Slowness Data Management System; and hardware products such as the Portable Free Eye-Seed Camera RC 350 series, and the Visual Screening VS 550 series。
Frequently asked questions
How many devices does Visionary Intelligence Ltd. have in the registry?
The registry currently lists 2 devices for Visionary Intelligence Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Visionary Intelligence Ltd.'s devices?
Among its 2 most recently registered devices, Visionary Intelligence Ltd. has devices listed in EUDAMED (2 devices).
What risk classes do Visionary Intelligence Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Visionary Intelligence Ltd.'s devices are Class I and Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Visionary Intelligence Ltd.?
EUDAMED lists 1 certificate for Visionary Intelligence Ltd. (quality management system) under MDR. The most recent was issued on 27 Feb 2025.
What are the newest devices from Visionary Intelligence Ltd. in the registry?
The most recently registered devices listed for Visionary Intelligence Ltd. include Fundus Image Analysis Software and EyeWisdom.