Singapore HSA registration DE0018162
Agfa DX-D 40 Digital Imaging System
Singapore·CLASS B·Agfa N.V.·Registered May 26, 2016Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0018162
- Registration Date
- May 26, 2016
- Change Notification Approval Date
- May 19, 2020
- Retention Due Date
- May 25, 2026
Product description
The DR Detector is a wireless radiographic digital X-ray imaging device commonly referred to as flat panel detector. It is designed for all general radiography applications. The DR Detector will be used in a radiological environment by qualified staff to capture the X-ray images and send these images to the imaging processing software. The DR Detector is not intended for mammography applications.
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)
- DX-D 40G DX-D 40C System Control Unit Mini System Control Unit Battery Charger Battery
- Model Identifier(s)
- 6007/100 6007/200 6007/300 6007/301 6007/303 FXRB-01A
About this record
Access comprehensive regulatory information for Agfa DX-D 40 Digital Imaging 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 DE0018162 and owned by Agfa N.V.. The device was registered on May 26, 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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