HSA · registration DE0510728Fujifilm Fujifilm Over-tubes
SingaporeGastroenterology & UrologyClass BFujifilm Corporation
Official record identity
- Registration number
- DE0510728
- Model name
- Over-tube; Over-tube
- Model identifier
- TR-1504A; TR-1507A
- Registration date
- May 15, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Fujifilm Corporation
- Registrant / registration holder
- FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- 26-30, Nishiazabu 2-chome, Minato-ku, Tokyo 106-8620, Japan
- Registrant address
- 20 PASIR PANJANG ROAD, #08-21, MAPLETREE BUSINESS CITY, Singapore 117439
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.