Singapore HSA registration DE0011475
Natus NeoBLUE Blanket LED Phototherapy System
Singapore·CLASS B·Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)·Registered October 30, 2012Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0011475
- Registration Date
- October 30, 2012
- Change Notification Approval Date
- April 29, 2022
- Retention Due Date
- October 29, 2025
Product description
The neoBLUE blanket LED Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in premature babies and neonates. It is intended for use with patients up to 3 months of age, weighing less than 22 lb (10 kg). It can be used in a hospital environment, and administered by trained professional medical staff, on the order of a physician, or in the home environment administered by a trained caregiver.
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)
- Disposable Covers, Large (Qty 50) Neoblue Blanket Phototherapy Neoblue blanket, Large Pad Kit Neoblue Blanket Phototherapy Disposable Covers, Small (Qty 50) Neoblue blanket, Small Pad Kit Mattress, Large (Qty 2) Mattress, Small (Qty 2) Neoblue Blanket Phototherapy Neoblue Blanket Phototherapy Neoblue Blanket Phototherapy Neoblue Blanket Phototherapy Neoblue Blanket Phototherapy Neoblue Blanket Phototherapy NeoBlue blanket LED Light Box NeoBlue blanket LED Light Box Biliband Eye Protector, Regular size Biliband Eye Protector, Premature Size Biliband Eye Protector, Micro Size
- Model Identifier(s)
- 005989 006244 006245 006895 006897 006898 007281 007283 007296 007298 007299 007300 007301 007302 024738 024915 900642 900643 900644
About this record
Access comprehensive regulatory information for Natus NeoBLUE Blanket 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 DE0011475 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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