Singapore HSA registration DE0508791
Shimadzu Surgical Mobile C-arm Imaging System Opescope Acteno
Singapore·CLASS C·Shimadzu Corporation·Registered December 27, 2023Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Radiology / Imaging
Registration information
- Registration Number
- DE0508791
- Registration Date
- December 27, 2023
- Retention Due Date
- December 26, 2025
Product description
This equipment is a mobile imaging system for X-ray fluoroscopy and radiography to be used during surgery as well as in X-ray examination rooms. This equipment is used for radiographic and fluoroscopy examinations of whole body except mammography. This equipment must only be operated by qualified personnel, such as radiography technicians or those with equivalent qualifications. This equipment is used for total patient population including pediatric examination
Product Owner
- Short Name
- Shimadzu Corporation
- Address
- 1 Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto 604-8511, JAPAN
Registrant
- Address
- 79 SCIENCE PARK DRIVE, CINTECH IV, #02-01/08, SINGAPORE 118264
Importer
- Address
- 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 196 PANDAN LOOP, PANTECH BUSINESS HUB, #04-29, SINGAPORE 128384 79 SCIENCE PARK DRIVE, CINTECH IV, #02-01, SINGAPORE 118264
Model information
- Model Name(s)
- SURGICAL MOBILE C-ARM SYSTEM OPESCOPE ACTENO (FD type
- Model Identifier(s)
- 566-28800
About this record
Access comprehensive regulatory information for Shimadzu Surgical Mobile C-arm Imaging System Opescope Acteno in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508791 and owned by Shimadzu Corporation. The device was registered on December 27, 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.
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