Singapore HSA registration DE0508659
Dräger Babyroo TN300 Radiant warmer
Singapore·CLASS C·Draeger Medical Systems, Inc.·Registered November 14, 2023Device 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 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).
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
About this record
Access comprehensive regulatory information for Dräger 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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