Singapore HSA registration DE0508090
Shimadzu Mobile X-ray System Mobirex i9
Singapore·CLASS C·Shimadzu Corporation·Registered May 15, 2023Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0508090
- Registration Date
- May 15, 2023
- Change Notification Approval Date
- September 19, 2024
- Retention Due Date
- May 14, 2025
Product description
This equipment is a mobile X-ray system for X-ray radiography. The system can be moved freely throughout a hospital to directly obtain X-ray images of various areas of the body. The system is used for radiographic examination of whole body except mammography. This system does not support long view radiography. This system must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. This system is used for total patient population including pediatric examination.
Product Owner
- Short Name
- Shimadzu Corporation
- Address
- Medical Systems Division, 1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto, 604-8511, 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)
- Additional hand switch Keyless entry Mobile X-ray System Mobirex i9 CXDI-702C Wireless CXDI-402C Wireless CXDI Control Software NE CXDI-710C Wireless CXDI-810C Wireless CXDI-410C Wireless CXDI-703C Wireless CXDI-803C Wireless CXDI-403C Wireless CXDI-720C Wireless CXDI-820C Wireless CXDI-420C Wireless
- Model Identifier(s)
- 563-70589-01 563-71058-02 566-20000-36 AR-C3543W AR-C4343W CXDI-CS01 WM5A11 WM5A12 WM5A13 WM5B01 WM5B02 WM5B03 WM5B04 WM5B05 WM5B06
About this record
Access comprehensive regulatory information for Shimadzu Mobile X-ray System Mobirex i9 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508090 and owned by Shimadzu Corporation. The device was registered on May 15, 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