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Singapore HSA registration DE0503272

Lumitex Medical Devices BiliSoft® 2.0 Phototherapy System

Singapore flagSingapore·CLASS B·Lumitex Medical Devices, Inc.·Registered June 22, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0503272
Registration Date
June 22, 2019
Retention Due Date
June 21, 2025
Product description
The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.
Product Owner
Name
Lumitex Medical Devices, Inc.
Short Name
Lumitex Medical Devices, Inc.
Address
8443 Dow Circle, Strongsville OH 44136, USA, UNITED STATES
Registrant
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Name
GE HEALTHCARE PTE. LTD.
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
Model Name(s)
BiliSoft 2.0 Fiberoptic Pad, Large BiliSoft 2.0 Fiberoptic Pad, Small BiliSoft 2.0 Phototherapy System BiliSoft 2.0 Phototherapy System
Model Identifier(s)
2104628-001 2104629-001 2108664-001 2108732-001
About this record

Access comprehensive regulatory information for Lumitex Medical Devices BiliSoft® 2.0 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 DE0503272 and owned by Lumitex Medical Devices, Inc.. The device was registered on June 22, 2019.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B