Singapore HSA registration DE0502739
Canon Raffine-i Remote Control R/F System
Singapore·CLASS C·Canon Medical Systems Corporation·Registered January 30, 2019Device 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 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
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C