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Draeger BiliLux LED Phototherapy Light - HSA Registration DE0500894

Access comprehensive regulatory information for Draeger BiliLux LED Phototherapy Light in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0500894 and owned by Draeger Medical Systems, Inc.. The device was registered on November 20, 2017.

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
DE0500894
Draeger BiliLux LED Phototherapy Light
HSA Registration Number: DE0500894
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Product Description

The BiliLux phototherapy light is designed to reduce the serum bilirubin concentration in premature babies and neonates with hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0500894
Registration Date
November 20, 2017
Retention Due Date
November 19, 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)
BiliLux
Model Identifier(s)
MU20100