Singapore HSA registration DE0505469
Fujifilm Endoscopy Support Program
Singapore·CLASS B·Fujifilm Corporation·Registered February 16, 2021Device 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 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
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
About this record
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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