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HSA · registration DE0510726

Lumetix BiliSoft® 2.0 Phototherapy System

SingaporeGeneral HospitalClass BLumitex Medical Devices, Inc.
Verified
Official record identity
Registration number
DE0510726
Model name
BiliSoft 2.0 Fiberoptic Pad, Large; BiliSoft 2.0 Fiberoptic Pad, Small; BiliSoft 2.0 Phototherapy System; BiliSoft 2.0 Phototherapy System
Model identifier
2104628-001; 2104629-001; 2108664-001; 2108732-001
Registration date
May 14, 2025
Classification
Risk class
Class B
Official value: CLASS B
Published category
General Hospital
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Published parties
Product owner
Lumitex Medical Devices, Inc.
Registrant / registration holder
GE HEALTHCARE PTE. LTD.
Official 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.

Additional source fields
Product owner address
6611 W. Snowville Rd.,, Brecksville, OH 44141,, United States
Registrant address
11 NORTH BUONA VISTA DRIVE, #11-07, THE METROPOLIS, Singapore 138589
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.