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FUJIFILM Fujifilm Ultrasonic Endoscope - HSA Registration DE0508523

Access comprehensive regulatory information for FUJIFILM Fujifilm Ultrasonic Endoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508523 and owned by Fujifilm Corporation. The device was registered on September 28, 2023.

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
DE0508523
FUJIFILM Fujifilm Ultrasonic Endoscope
HSA Registration Number: DE0508523
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Product 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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0508523
Registration Date
September 28, 2023
Retention Due Date
September 27, 2025
Product Owner
Short Name
Fujifilm Corporation
Address
26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, JAPAN
Registrant
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model Information
Model Name(s)
Air/Water Valve Balloon for Ultrasonography Ultrasonic Endoscope EG-740UT Forceps Valve Suction Valve Water Tank
Model Identifier(s)
AW-602 BS-102 EG-740UT FV-002 SB-604 WT-603