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HSA · registration DE0508523

FUJIFILM Fujifilm Ultrasonic Endoscope

SingaporeGastroenterology & UrologyClass BFujifilm Corporation
Verified
Official record identity
Registration number
DE0508523
Model name
Air/Water Valve; Balloon for Ultrasonography; Ultrasonic Endoscope EG-740UT; Forceps Valve; Suction Valve; Water Tank
Model identifier
AW-602; BS-102; EG-740UT; FV-002; SB-604; WT-603
Registration date
September 28, 2023
Classification
Risk class
Class B
Official value: CLASS B
Published category
Gastroenterology & Urology
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Published parties
Product owner
Fujifilm Corporation
Registrant / registration holder
FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD.
Official description

Ultrasonic Endoscope Model EG-740UT is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of submucosal and peripheral organs of the esophagus, stomach, and duodenum. Never use this product for any other purposes. This product is not intended for use on children and infants.

Additional source fields
Product owner address
26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan
Registrant address
20 PASIR PANJANG ROAD, #08-21, MAPLETREE BUSINESS CITY, Singapore 117439
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.