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Fujifilm Endoscopy Support Program - HSA Registration DE0505469

Access comprehensive regulatory information for Fujifilm Endoscopy Support Program in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505469 and owned by Fujifilm Corporation. The device was registered on February 16, 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
DE0505469
Fujifilm Endoscopy Support Program
HSA Registration Number: DE0505469
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Product Description

This software detects and characterizes an area suspected to be a colonic polyp in an endoscopic video image outputted from an endoscopic video processor. The software superimposes the result of Detection Mode or Characterization Mode onto the endoscopic video image and displays on the monitor in real-time. This software is intended to be used to support diagnosis during colonoscopy under the supervision of medical professionals

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0505469
Registration Date
February 16, 2021
Change Notification Approval Date
March 22, 2024
Retention Due Date
February 15, 2026
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)
Endoscopy Support Program
Model Identifier(s)
EW10-EC02