Singapore HSA registration DE0508919
WiScope® Digital Cystoscope System
Singapore·CLASS B·OTU MEDICAL·Registered February 02, 2024Device 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 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.
Product Owner
- Name
- OTU MEDICAL
- 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
About this record
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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