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Olympus IR Telescope - HSA Registration DE0501648

Access comprehensive regulatory information for Olympus IR Telescope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501648 and owned by Olympus Winter & Ibe GmbH. The device was registered on May 17, 2018.

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
DE0501648
Olympus IR Telescope
HSA Registration Number: DE0501648
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Product Description

Telescope intended for visualization using a compatible imaging system for white light imaging and fluorescence imaging. Visualization includes: laparoscopy, thoracoscopy, transanal procedures, transvaginal procedures. Only for use by a qualified physician in an adequate medical environment

Device Classification
Device Class
CLASS B
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0501648
Registration Date
May 17, 2018
Change Notification Approval Date
August 04, 2021
Retention Due Date
May 16, 2026
Product Owner
Short Name
Olympus
Address
Kuehnstrasse 61, 22045 Hamburg, GERMANY
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)
Telescope, 10mm, 0°, IR Telescope, 10mm, 30°, IR Telescope, 5.4mm, 0°, IR Telescope, 5.4mm, 30°, IR
Model Identifier(s)
WAIR100A WAIR130A WAIR500A WAIR530A