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Olympus SutuArt Single Use Needle Holder FG-260 - HSA Registration DE0509495

Access comprehensive regulatory information for Olympus SutuArt Single Use Needle Holder FG-260 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509495 and owned by Olympus Medical Systems Corp.. The device was registered on July 05, 2024.

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
DE0509495
Olympus SutuArt Single Use Needle Holder FG-260
HSA Registration Number: DE0509495
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Product Description

The Single Use Needle Holder has been designed to be used with an Olympus endoscope to grasp and hold a suture needle or a suture in mucosal defect closure procedure within the stomach, colon and rectum.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509495
Registration Date
July 05, 2024
Retention Due Date
July 04, 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)
Single Use Needle Holder FG-260 Single Use Needle Holder FG-260
Model Identifier(s)
FG-260L FG-260U