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Agfa Healthcare Enterprise Imaging XERO Viewer - HSA Registration DE0018535

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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CLASS B
DE0018535
Agfa Healthcare Enterprise Imaging XERO Viewer
HSA Registration Number: DE0018535
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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.

Device 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 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