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Singapore HSA registration DE0508480

FUJIFILM FDR CROSS Mobile Digital X-Ray Fluoroscopy System

Singapore flagSingapore·CLASS C·FUJIFILM CORPORATION·Registered September 13, 2023
Device classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0508480
Registration Date
September 13, 2023
Retention Due Date
September 12, 2025
Product description
The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, peripheral vascular, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography.
Product Owner
Name
FUJIFILM CORPORATION
Short Name
FUJIFILM
Address
26-30 nishiazabu 2 chome, MINATO-KU TOKYO 106-8620 JAPAN, JAPAN
Registrant
Name
FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
Name
FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
Model Name(s)
MOBILE DIGITAL X-RAY SYSTEM
Model Identifier(s)
DR-XD 3000
About this record

Access comprehensive regulatory information for FUJIFILM FDR CROSS Mobile Digital X-Ray Fluoroscopy System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508480 and owned by FUJIFILM CORPORATION. The device was registered on September 13, 2023.

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 DatabasePowered by Pure Global AIHSA Official DataCLASS C