Singapore HSA registration DE0501648
Olympus IR Telescope
Singapore·CLASS B·Olympus Winter & Ibe GmbH·Registered May 17, 2018Device 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 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
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B