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Drรคger Babyroo TN300 Radiant warmer - HSA Registration DE0508659

Access comprehensive regulatory information for Drรคger Babyroo TN300 Radiant warmer in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508659 and owned by Draeger Medical Systems, Inc.. The device was registered on November 14, 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
DE0508659
Drรคger Babyroo TN300 Radiant warmer
HSA Registration Number: DE0508659
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Product Description

The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) and pulse oximetry (optional) of neonates and infants. The device is designed for use with patients with a body weight up to 10 kg (22 lb).

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508659
Registration Date
November 14, 2023
Retention Due Date
November 13, 2025
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)
Babyroo TN300
Model Identifier(s)
MU20300