Singapore HSA registration DE0017017
Agfa CR30-Xm Digitizer System
Singapore·CLASS B·Agfa N.V.·Registered April 16, 2015Device 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 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
Product Owner
- Name
- Agfa N.V.
- 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
About this record
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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