Singapore HSA registration DE0508713
Stryker SPY® Laparoscopes
Singapore·CLASS B·Stryker Endoscopy·Registered December 01, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General & Plastic Surgery
Registration information
- Registration Number
- DE0508713
- Registration Date
- December 01, 2023
- Change Notification Approval Date
- October 29, 2024
- Retention Due Date
- November 30, 2025
Product description
The SPY® Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.
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® Laparoscope, Autoclavable, 5.4 mm x 0°, 30cm SPY® Laparoscope, Autoclavable, 5.4 mm x 30°, 30cm SPY® Laparoscope, Autoclavable, 5.4 mm x 45°, 30cm SPY® Bariatric Laparoscope, Autoclavable, 5.4 mm x 0°, 45cm SPY® Bariatric Laparoscope, Autoclavable, 5.4 mm x 30°, 45cm SPY® Bariatric Laparoscope, Autoclavable, 5.4 mm x 45°, 45cm SPY® Laparoscope, Autoclavable, 10mm x 0°, 33cm SPY® Laparoscope, Autoclavable, 10mm x 30°, 33cm SPY® Laparoscope, Autoclavable, 10mm x 45°, 33cm SPY® Bariatric Laparoscope, Autoclavable, 10mm x 0°, 45cm SPY® Bariatric Laparoscope, Autoclavable, 10mm x 30°, 45cm SPY® Bariatric Laparoscope, Autoclavable, 10mm x 45°, 45cm
- Model Identifier(s)
- 0502-538-010 0502-538-030 0502-538-045 0502-548-010 0502-548-030 0502-548-045 0502-938-010 0502-938-030 0502-938-045 0502-948-010 0502-948-030 0502-948-045
About this record
Access comprehensive regulatory information for Stryker SPY® Laparoscopes in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508713 and owned by Stryker Endoscopy. The device was registered on December 01, 2023.
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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