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Lumetix BiliSoftยฎ 2.0 Phototherapy System - HSA Registration DE0510726

Access comprehensive regulatory information for Lumetix BiliSoftยฎ 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 DE0510726 and owned by Lumitex Medical Devices, Inc.. The device was registered on May 14, 2025.

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
DE0510726
Lumetix BiliSoftยฎ 2.0 Phototherapy System
HSA Registration Number: DE0510726
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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.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510726
Registration Date
May 14, 2025
Retention Due Date
May 13, 2026
Product Owner
Short Name
Lumitex Medical Devices, Inc.
Address
6611 W. Snowville Rd.,, Brecksville, OH 44141,, UNITED STATES
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
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