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Agfa CR30-Xm Digitizer System - HSA Registration DE0017017

Access comprehensive regulatory information for Agfa CR30-Xm Digitizer System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017017 and owned by Agfa N.V.. The device was registered on April 16, 2015.

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
DE0017017
Agfa CR30-Xm Digitizer System
HSA Registration Number: DE0017017
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Product Description

This device must only be used to scan exposed X-ray cassettes, containing an erasable image plate (IP). The digitizer is part of a system, consisting of X-ray cassettes with erasable phosphor image plates and a workstation where the X-ray cassettes are identified and the resulting digital image information is further processed and routed. It is intended that this device is only operated in a radiological environment by qualified staff

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0017017
Registration Date
April 16, 2015
Change Notification Approval Date
May 19, 2020
Retention Due Date
April 15, 2026
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)
CR 30-Xm
Model Identifier(s)
5179/100