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Shimadzu EZy-Rad Pro X-ray system - HSA Registration DE0012715

Access comprehensive regulatory information for Shimadzu EZy-Rad Pro X-ray 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 DE0012715 and owned by Shimadzu Corporation. The device was registered on April 03, 2013.

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
DE0012715
Shimadzu EZy-Rad Pro X-ray system
HSA Registration Number: DE0012715
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Product Description

General radiography system to acquire images from an X-Ray radiography table, using film in a cassette. This system is mainly composed of X-ray tube, X-Ray radiography table, X-Ray collimator, X-ray high voltage generator.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0012715
Registration Date
April 03, 2013
Change Notification Approval Date
September 05, 2018
Retention Due Date
April 02, 2026
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
79 SCIENCE PARK DRIVE, CINTECH IV, #02-01, SINGAPORE 118264
Model Information
Model Name(s)
200mAs option (only for AH or MH pack) BR photo kit Communication unit Hand switch Photo timer kit P-C/CH SPT-XD-A3B-XSY Phototimer pick-up (3 fields pick-up) EZy-Rad Pro A pack EZy-Rad Pro M pack EZy-Rad Pro AH pack EZy-Rad Pro MH pack BR-120M (STD) Wall bucky stand
Model Identifier(s)
200mAs option PCH BR Phototimer Kit Communication Unit Handswitch Phototimer Kit Xsy Phototimer SPT-XD-A3B UD125P-C-PRO UD125P-C2-PRO UD125P-CH-PRO UD125P-CH2-PRO X-Ray Radiography Stand BR-120M