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Shimadzu Surgical Mobile C-arm Imaging System Opescope Acteno - HSA Registration DE0508791

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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CLASS C
DE0508791
Shimadzu Surgical Mobile C-arm Imaging System Opescope Acteno
HSA Registration Number: DE0508791
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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

Device 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 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