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HSA · registration DE0509495

Olympus SutuArt Single Use Needle Holder FG-260

SingaporeGastroenterology & UrologyClass BOlympus Medical Systems Corp.
Verified
Official record identity
Registration number
DE0509495
Model name
Single Use Needle Holder FG-260; Single Use Needle Holder FG-260
Model identifier
FG-260L; FG-260U
Registration date
July 05, 2024
Classification
Risk class
Class B
Official value: CLASS B
Published category
Gastroenterology & Urology
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Published parties
Product owner
Olympus Medical Systems Corp.
Registrant / registration holder
OLYMPUS SINGAPORE PTE. LTD.
Official 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.

Additional source fields
Product owner address
2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan
Registrant address
438B ALEXANDRA ROAD, #03-07/12, ALEXANDRA TECHNOPARK, Singapore 119968
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.