HSA · registration DE0509165

EVIS EUS ENDOSCOPIC Ultrasound Center

Name: EVIS EUS ENDOSCOPIC Ultrasound Center — HSA DE0509165
Creator: Olympus Medical Systems Corp.
Keywords: EVIS EUS ENDOSCOPIC Ultrasound Center, EVIS EUS ENDOSCOPIC Ultrasound Center, DE0509165, Gastroenterology & Urology, HSA

SingaporeGastroenterology & UrologyClass BOlympus Medical Systems Corp.

Verified

Official record identity

Registration number: DE0509165
Model name: EVIS EUS ENDOSCOPIC Ultrasound Center; Keyboard; CHE Software option; ELST Software option; SWQ Software option
Model identifier: EU-ME3; MAJ-2380; MAJ-2381; MAJ-2382; MAJ-2383
Registration date: April 12, 2024

Classification

Risk class: Class B
Published category: Gastroenterology & Urology

Published parties

Product owner: Olympus Medical Systems Corp.
Registrant / registration holder: OLYMPUS SINGAPORE PTE. LTD.

Official 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.

Additional source fields

Product owner address: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan
Registrant address: 438B ALEXANDRA ROAD, #03-07/12, ALEXANDRA TECHNOPARK, Singapore 119968

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.