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Olympus ENDOEYE FLEX 3D Deflectable Videoscope - HSA Registration DE0505955

Access comprehensive regulatory information for Olympus ENDOEYE FLEX 3D Deflectable Videoscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505955 and owned by Olympus Medical Systems Corp.. The device was registered on July 01, 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
DE0505955
Olympus ENDOEYE FLEX 3D Deflectable Videoscope
HSA Registration Number: DE0505955
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Product Description

This instrument is intended to be used with Olympus video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the thoracic and abdominal cavities including female reproductive organs as well as anal, rectum, and areas approached through anal and rectum.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0505955
Registration Date
July 01, 2021
Change Notification Approval Date
October 21, 2021
Retention Due Date
June 30, 2026
Product Owner
Short Name
Olympus
Address
2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, JAPAN
Registrant
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Importer
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #03-07/12, SINGAPORE 119968
Model Information
Model Name(s)
ENDOEYE FLEX 3D Deflectable Videoscope
Model Identifier(s)
LTF-S300-10-3D