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Agfa NX Software - HSA Registration DE0014447

Access comprehensive regulatory information for Agfa NX Software in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0014447 and owned by Agfa N.V.. The device was registered on December 16, 2013.

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 C
DE0014447
Agfa NX Software
HSA Registration Number: DE0014447
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Product Description

Agfa HealthCare NX Software is intended for image acquisition, identification, image processing and image transmission of digitized images received from an Agfa digitizer or Agfa validated DR Panel.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0014447
Registration Date
December 16, 2013
Change Notification Approval Date
May 19, 2020
Retention Due Date
December 15, 2025
Product Owner
Short Name
Agfa N.V.
Address
Septestraat 27, 2640 Mortsel, BELGIUM
Registrant
Address
506 CHAI CHEE LANE, BOXPARK @ CHAI CHEE, #07-02, SINGAPORE 469026
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)
Agfa NX Agfa NX
Model Identifier(s)
2.0 3.0