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SPY Cystoscope/Hysteroscope - HSA Registration DE0510057

Access comprehensive regulatory information for SPY Cystoscope/Hysteroscope in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510057 and owned by Stryker Endoscopy. The device was registered on November 20, 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
DE0510057
SPY Cystoscope/Hysteroscope
HSA Registration Number: DE0510057
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Product Description

The SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration Information
Registration Number
DE0510057
Registration Date
November 20, 2024
Retention Due Date
November 19, 2025
Product Owner
Short Name
Stryker
Address
5900 Optical Court, San Jose, CA 95138, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
SPY® Cystoscope/Hysteroscope, Autoclavable, Speed-Lock™, 4mm x 0°, 30cm SPY® Cystoscope/Hysteroscope, Autoclavable, Speed-Lock™, 4mm x 12°, 30cm SPY® Cystoscope/Hysteroscope, Autoclavable, Speed-Lock™, 4mm x 30°, 30cm SPY® Cystoscope/Hysteroscope, Autoclavable, Speed-Lock™, 4mm x 70°, 30cm SPY® Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4mm x 0°, 30cm SPY® Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4mm x 12°, 30cm SPY® Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4mm x 30°, 30cm SPY® Cystoscope/Hysteroscope, Autoclavable, KS-Series, 4mm x 70°, 30cm
Model Identifier(s)
0502-720-010 0502-720-012 0502-720-030 0502-720-070 0502-721-010 0502-721-012 0502-721-030 0502-721-070