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OTU WiScope Digital Endoscope System - HSA Registration DE0505364

Access comprehensive regulatory information for OTU WiScope Digital Endoscope System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505364 and owned by OTU Medical Inc. The device was registered on January 19, 2021.

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
DE0505364
OTU WiScope Digital Endoscope System
HSA Registration Number: DE0505364
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Product Description

WiScope® Digital Endoscope System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0505364
Registration Date
January 19, 2021
Retention Due Date
January 18, 2026
Product Owner
Short Name
OTU Medical Inc
Address
2231A Fortune Drive, San Jose, CA, 95131, UNITED STATES
Registrant
Address
2 ANG MO KIO STREET 64, ECON INDUSTRIAL BUILDING, #05-02A, SINGAPORE 569084
Importer
Address
40 JALAN PEMIMPIN, TAT ANN BUILDING, #03-01C, SINGAPORE 577185
Model Information
Model Name(s)
WiScope®Single-Use Digital Flexible Ureteroscope, Reverse Deflection model WiScope®Single-Use Digital Flexible Ureteroscope, Reverse Deflection model WiScope®Single-Use Digital Flexible Ureteroscope, Standard Deflection model WiScope®Single-Use Digital Flexible Ureteroscope, Standard Deflection model WiScope�Image System
Model Identifier(s)
OTU-100RL OTU-100RR OTU-100SL OTU-100SR OTU-A