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Stryker Connected OR Hub - HSA Registration DE0505586

Access comprehensive regulatory information for Stryker Connected OR Hub in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505586 and owned by Stryker Endoscopy. The device was registered on March 24, 2021.

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
DE0505586
Stryker Connected OR Hub
HSA Registration Number: DE0505586
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Product Description

The use of the Connected OR Hub 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 Connected OR Hub 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 & Plastic Surgery
Registration Information
Registration Number
DE0505586
Registration Date
March 24, 2021
Change Notification Approval Date
August 14, 2024
Retention Due Date
March 23, 2026
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)
Connected OR Hub Device Management Control System Connected OR Hub VIP Package Voice Package Device Control Package Replacement IR Remote Control Connected OR Hub Device Management Control System
Model Identifier(s)
0240-200-100 240200101 240200102 240200103 240200112 240200200