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OTU Medical WiScope® Digital Endoscope System - HSA Registration DE0508881

Access comprehensive regulatory information for OTU Medical 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 DE0508881 and owned by OTU Medical Inc.. The device was registered on January 23, 2024.

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
DE0508881
OTU Medical WiScope® Digital Endoscope System
HSA Registration Number: DE0508881
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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
Radiology / Imaging
Registration Information
Registration Number
DE0508881
Registration Date
January 23, 2024
Retention Due Date
January 22, 2026
Product Owner
Short Name
OTU Medical Inc.
Address
2847A Whipple Road, Union City, CA 94587, 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 Endoscope, Reverse Deflection model WiScope® Single-Use Digital Flexible Ureteroscope, Reverse Deflection model WiScope® Single-Use Digital Flexible Ureteroscope, Standard Deflection model WiScope� Digital Endoscope System
Model Identifier(s)
OTU-100SL OTU-120R OTU-120S OTU-A