Pure Global

Agfa DX-D 40 Digital Imaging System - HSA Registration DE0018162

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0018162
Agfa DX-D 40 Digital Imaging System
HSA Registration Number: DE0018162
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device 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 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)
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