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Canon Raffine-i Remote Control R/F System - HSA Registration DE0502739

Access comprehensive regulatory information for Canon Raffine-i Remote Control R/F 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 DE0502739 and owned by Canon Medical Systems Corporation. The device was registered on January 30, 2019.

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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CLASS C
DE0502739
Canon Raffine-i Remote Control R/F System
HSA Registration Number: DE0502739
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Product Description

This system is intended for use in gastrointestinal examinations and the other X-ray examinations specified below. • Gastrointestinal angiography, support for endoscopy • General radiography (general abdominal radiography, general skeletal radiography) • Nonvascular angiography (cholangiography, myelography, arthrography, etc.) • ERCP, PTC

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0502739
Registration Date
January 30, 2019
Change Notification Approval Date
July 25, 2022
Retention Due Date
January 29, 2026
Product Owner
Short Name
Canon Medical Systems Corporation
Address
1385 Shimoishigami, Otawara-Shi,, Tochigi 324-8550, JAPAN
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Importer
Address
211 HENDERSON ROAD, 211 HENDERSON, #08-02, SINGAPORE 159552
Model Information
Model Name(s)
REMOTE CONTROL R/F SYSTEMRaffine-i REMOTE CONTROL R/F SYSTEMRaffine-i REMOTE CONTROL R/F SYSTEMRaffine-i REMOTE CONTROL R/F SYSTEMRaffine-i 　Fiber-type detector for Bucky Stand 　X-ray beam limiting device 　X-ray beam limiting device 　Vertical Bucky stand 　Patient compression band 　Cassette holder for 14" × 17" cassette X-ray diagnostic table 　Front cover switches 　Remote control console 　Subdesk 　Ceiling rails 　Ceiling-suspended tube support 　Footswitch 　X-ray high-voltage generator 　Local control console 　Image processor (DR system) 　Fluoroscopic digital compensation filter 　Dynamic image file saving function 　Patient information automatic reading function 　DICOM multiviewer 　Cart for 1 monitor 　Table mat 　Mechanical stop unit 　System monitor
Model Identifier(s)
DREX-RF80/W1 DREX-RF80/W2 DREX-RF80/W3 DREX-RF80/W4 PTF-100L/01 　BLF-100A 　BLR-1000A/G1 　BS-02A/G1 　CD-10W 　CHK-4000F 　DBK-4000A 　DBKK-FCSW 　DCD-08A 　DSK-045A 　DSR-1030B/W1 　DST-1000A/G1 　FSW-20BR 　KXO-85SF 　LCK-24A 　PDR-04A 　PDRK-FDCF 　PDRK-MOVIE 　PDRK-PAT/MP 　PDRK-QRSCU 　XAMC-100L/L2 　XBTA-001A 　XGST-MACS/03 　XLCD-23W