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Olympus TriangleTipKnife J Single Use Electrosurgical Knife - HSA Registration DE0018953

Access comprehensive regulatory information for Olympus TriangleTipKnife J Single Use Electrosurgical Knife in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0018953 and owned by Olympus Medical Systems Corporation. The device was registered on February 10, 2017.

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
DE0018953
Olympus TriangleTipKnife J Single Use Electrosurgical Knife
HSA Registration Number: DE0018953
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Product Description

This instrument has been designed to be used with Olympus endoscopes, electrosurgical units to cut and coagulate tissue using high-frequency current and flushing devices for submucosal injection within the digestive tract.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0018953
Registration Date
February 10, 2017
Change Notification Approval Date
March 04, 2021
Retention Due Date
February 09, 2026
Product Owner
Short Name
Olympus Medical Systems
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)
Single Use Electrosurgical Knife KD-645
Model Identifier(s)
KD-645L