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Olympus EVIS X1 Video System Center - HSA Registration DE0504782

Access comprehensive regulatory information for Olympus EVIS X1 Video System Center in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504782 and owned by Olympus Medical Systems Corporation. The device was registered on August 05, 2020.

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 B
DE0504782
Olympus EVIS X1 Video System Center
HSA Registration Number: DE0504782
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Product Description

This video system center is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor of ancillary equipment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504782
Registration Date
August 05, 2020
Change Notification Approval Date
July 24, 2024
Retention Due Date
August 04, 2025
Product Owner
Short Name
Olympus Medical Systems
Address
2951 Ishikawa-cho, Hachioji-Shi, Tokyo 192-8507,, JAPAN
Registrant
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Importer
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Model Information
Model Name(s)
EVIS X1 Video System Center
Model Identifier(s)
CV-1500