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Olympus PowerSpiral Control Unit - HSA Registration DE0507447

Access comprehensive regulatory information for Olympus PowerSpiral Control Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507447 and owned by Olympus Medical Systems Corp.. The device was registered on November 03, 2022.

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
DE0507447
Olympus PowerSpiral Control Unit
HSA Registration Number: DE0507447
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Product Description

This PowerSpiral control unit is intended to facilitate the insertion of the Olympus-designated intestinal endoscope by rotating the single use PowerSpiral tube clockwise and counterclockwise.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0507447
Registration Date
November 03, 2022
Retention Due Date
November 02, 2025
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)
PowerSpiral Control Unit
Model Identifier(s)
PSCU