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Stryker SPY® Laparoscopes - HSA Registration DE0508713

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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CLASS B
DE0508713
Stryker SPY® Laparoscopes
HSA Registration Number: DE0508713
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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.

Device 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 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