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Agfa Healthcare Enterprise Imaging Desktops - HSA Registration DE0017942

Access comprehensive regulatory information for Agfa Healthcare Enterprise Imaging Desktops in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017942 and owned by Agfa Healthcare N.V.. The device was registered on March 15, 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
DE0017942
Agfa Healthcare Enterprise Imaging Desktops
HSA Registration Number: DE0017942
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Product Description

Agfa HealthCare Enterprise Imaging provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
HSAMDB00112
HS Code
90229090
Registration Information
Registration Number
DE0017942
Registration Date
March 15, 2016
Change Notification Approval Date
July 16, 2024
Retention Due Date
March 14, 2026
Product Owner
Short Name
Agfa Healthcare N.V.
Address
Septestraat 27,, 2640 Mortsel, 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)
Acquisition Desktop Administrator Desktop Clinician Desktop Diagnostic Desktop Medical Seretary Desktop
Model Identifier(s)
Acquisition Desktop 8.x Administrator Desktop 8.x Clinician Desktop 8.x Diagnostic Desktop 8.x Medical Seretary Desktop 8.x