Singapore HSA registration DE0508554
Stryker SDC4K Information Management System
Singapore·CLASS C·Stryker Endoscopy·Registered October 09, 2023Device 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 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.
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
About this record
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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