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Stryker SDC4K Information Management System - HSA Registration DE0508554

Access comprehensive regulatory information for Stryker SDC4K Information Management System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508554 and owned by Stryker Endoscopy. The device was registered on October 09, 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 C
DE0508554
Stryker SDC4K Information Management System
HSA Registration Number: DE0508554
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Product Description

The use of the SDC4K with Device and Voice Control system is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K with Device and Voice Control or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality to electronically capture, transfer, store and display medical device data, which is independent of the functions or parameters of any attached Stryker device.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508554
Registration Date
October 09, 2023
Change Notification Approval Date
August 14, 2024
Retention Due Date
October 08, 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)
Voice Package Device Control Package SDC4K Information Management System SDC4K Information Management System
Model Identifier(s)
240200102 240200103 240300100 240300200