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Drรคger Infinity Gateway Suite - HSA Registration DE0506585

Access comprehensive regulatory information for Drรคger Infinity Gateway Suite in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506585 and owned by Draeger Medical Systems, Inc.. The device was registered on January 21, 2022.

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
DE0506585
Drรคger Infinity Gateway Suite
HSA Registration Number: DE0506585
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Product Description

The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity network and for data exchange of select clinical and administrative information between the Infinity network and the hospital network.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0506585
Registration Date
January 21, 2022
Change Notification Approval Date
August 23, 2022
Retention Due Date
January 20, 2026
Product Owner
Short Name
Draeger Medical
Address
3135 Quarry Road, Telford, PA 18969, UNITED STATES
Registrant
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Importer
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Model Information
Model Name(s)
Infinity Gateway Software
Model Identifier(s)
MS40545