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Natus NeoBlue LED Phototherapy System - HSA Registration DE0011476

Access comprehensive regulatory information for Natus NeoBlue LED Phototherapy System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0011476 and owned by Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK). The device was registered on October 30, 2012.

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
DE0011476
Natus NeoBlue LED Phototherapy System
HSA Registration Number: DE0011476
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Product Description

It is intended for the treatment of neonatal hyperbilirubinemia.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00104
HS Code
90189030
Registration Information
Registration Number
DE0011476
Registration Date
October 30, 2012
Change Notification Approval Date
April 29, 2022
Retention Due Date
October 29, 2025
Product Owner
Short Name
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
Address
2568 Bristol Circle, Oakville, Ontario, L6H 5S1, CANADA
Registrant
Address
81 TOH GUAN ROAD EAST, SECOM CENTRE, #03-01, SINGAPORE 608606
Importer
Address
81 TOH GUAN ROAD EAST, SECOM CENTRE, #03-01, SINGAPORE 608606 81 TOH GUAN ROAD EAST, #03-01, SINGAPORE 608606
Model Information
Model Name(s)
neoBLUE® LED Phototherapy (Light only with timer, 115v 50/60Hz Kit) Drape for Neoblue 3 light Light Enclosure neoBLUE® LED Phototherapy (Light only with timer, Europe 50/60Hz Kit) neoBLUE® LED Phototherapy (Device 230v, UK 50/60Hz Kit) neoBLUE® LED PhototherapyL(ight only with timer, Australia 50/60Hz Kit) neoBLUE® LED Phototherapy (Device 115v, 50/60Hz Kit) neoBLUE® LED Phototherapy (Device 230v, Europe 50/60 Hz Kit) neoBLUE® LED Phototherapy (Device 230v, UK 50/60Hz Kit) neoBLUE® LED Phototherapy (Device 230v, Australia 50/60Hz Kit) neoBLUE® compact LED Phototherapy neoBLUE® compact System neoBLUE® compact System w/Arm neoBLUE® compact Arm neoBLUE® compact Rollstand neoBLUE® LED Phototherapy (Device with timer 115v, 50/60Hz Kit) neoBLUE® LED Phototherapy (Device with timer 230v, 50/60Hz Kit) Biliband Eye Protector, Regular size Biliband Eye Protector, Premature Size Biliband Eye Protector, Micro Size
Model Identifier(s)
001103 001241 001376 001378 001379 001380 010066 010068 010069 010070 018000 019003 019013 019030 019040 040904 040906 900642 900643 900644