Singapore HSA registration DE0018535
Agfa Healthcare Enterprise Imaging XERO Viewer
Singapore·CLASS B·Agfa Healthcare N.V.·Registered September 08, 2016Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0018535
- Registration Date
- September 08, 2016
- Change Notification Approval Date
- May 03, 2023
- Retention Due Date
- September 07, 2025
Product description
Agfa HealthCare Enterprise Imaging XERO Viewer is a software application used for reference viewing of medical images and associated reports and, which enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi-disciplinary viewer.
Product Owner
- Short Name
- Agfa Healthcare N.V.
- Address
- Septestraat 27,, B-2640 Morstel,, BELGIUM
Registrant
- Address
- 62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734
Importer
- Address
- 62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734 506 CHAI CHEE LANE, BOXPARK @ CHAI CHEE, #07-02, SINGAPORE 469026
Model information
- Model Name(s)
- Enterprise Imaging XERO Viewer 3D Enterprise Imaging XERO Viewer
- Model Identifier(s)
- 8.x 8.x
About this record
Access comprehensive regulatory information for Agfa Healthcare Enterprise Imaging XERO Viewer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018535 and owned by Agfa Healthcare N.V.. The device was registered on September 08, 2016.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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