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EVIS EUS ENDOSCOPIC Ultrasound Center - HSA Registration DE0509165

Access comprehensive regulatory information for EVIS EUS ENDOSCOPIC Ultrasound 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 DE0509165 and owned by Olympus Medical Systems Corp.. The device was registered on April 12, 2024.

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
DE0509165
EVIS EUS ENDOSCOPIC Ultrasound Center
HSA Registration Number: DE0509165
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Product Description

This ultrasound center is intended to be used with Olympus ultrasound endoscopes and Olympus ultrasound probes to observe as indicated within the gastrointestinal (GI) tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree and urinary tract. Do not use this device for any purpose other than its intended use.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509165
Registration Date
April 12, 2024
Retention Due Date
April 11, 2026
Product Owner
Short Name
Olympus
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 EUS ENDOSCOPIC Ultrasound Center Keyboard CHE Software option ELST Software option SWQ Software option
Model Identifier(s)
EU-ME3 MAJ-2380 MAJ-2381 MAJ-2382 MAJ-2383