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Fujifilm Fujifilm Over-tubes - HSA Registration DE0510728

Access comprehensive regulatory information for Fujifilm Fujifilm Over-tubes in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510728 and owned by Fujifilm Corporation. The device was registered on May 15, 2025.

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
DE0510728
Fujifilm Fujifilm Over-tubes
HSA Registration Number: DE0510728
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Product Description

This product is intended to be used in combination with an endoscope to assist endoscopic insertion into the body. Never use this product for any other purpose. This product is intended for use in medical facilities by medical professionals who are properly trained in using it as well as in endoscopic procedures and endoscopic treatments.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0510728
Registration Date
May 15, 2025
Retention Due Date
May 14, 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)
Over-tube Over-tube
Model Identifier(s)
TR-1504A TR-1507A