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Fujifilm Fujifilm Video Endoscope - HSA Registration DE0505965

Access comprehensive regulatory information for Fujifilm Fujifilm Video 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 DE0505965 and owned by Fujifilm Corporation. The device was registered on July 05, 2021.

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
DE0505965
Fujifilm Fujifilm Video Endoscope
HSA Registration Number: DE0505965
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Product Description

FUJIFILM Endoscope Model EI-740D/S endoscope is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This device is also intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0505965
Registration Date
July 05, 2021
Change Notification Approval Date
March 22, 2024
Retention Due Date
July 04, 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)
Fujifilm AW-603 Fujifilm Video Endoscope EI-740D/S Fujifilm FV-001 Fujifilm JT-500 Fujifilm SB-605
Model Identifier(s)
AW-603 EI-740D/S FV-001 JT-500 SB-605