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WiScope® Digital Cystoscope System - HSA Registration DE0508919

Access comprehensive regulatory information for WiScope® Digital Cystoscope 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 DE0508919 and owned by OTU MEDICAL. The device was registered on February 02, 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
DE0508919
WiScope® Digital Cystoscope System
HSA Registration Number: DE0508919
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Product Description

WiScope® Digital Cystoscope System is intended to be used by physicians to access, visualize, and perform procedures in the bladder and lower ureter. 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
DE0508919
Registration Date
February 02, 2024
Retention Due Date
February 01, 2026
Product Owner
Short Name
OTU MEDICAL
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 Cystoscope, Reverse Deflection model WiScope® Single-Use Digital Flexible Cystoscope, Standard Deflection model WiScope® Single-Use Digital Flexible Cystoscope, Reverse Deflection model WiScope® Single-Use Digital Flexible Cystoscope, Standard Deflection model
Model Identifier(s)
OTU-C300R OTU-C300S OTU-C310R OTU-C310S