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Singapore HSA registration DE0508794

FUJIFILM DIGITAL RADIOGRAPHY DR-ID 1800 Flat Panel Sensors

Singapore flagSingapore·CLASS B·FUJIFILM CORPORATION·Registered December 28, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0508794
Registration Date
December 28, 2023
Change Notification Approval Date
February 21, 2025
Retention Due Date
December 27, 2025
Product description
The FDR D-EVO III flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used.
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)
FLAT PANEL SENSOR FLAT PANEL SENSOR FLAT PANEL SENSOR FLAT PANEL SENSOR FLAT PANEL SENSOR FLAT PANEL SENSOR DR-ID1200MC
Model Identifier(s)
DR-ID 1811SE DR-ID 1812SE DR-ID 1814SE DR-ID 1831SE DR-ID 1832SE DR-ID 1836SE DR-ID1200MC
About this record

Access comprehensive regulatory information for FUJIFILM DIGITAL RADIOGRAPHY DR-ID 1800 Flat Panel Sensors in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508794 and owned by FUJIFILM CORPORATION. The device was registered on December 28, 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 B