Bistos Infant Phototherapy Equipment (BT-450) - HSA Registration DE0508275
Access comprehensive regulatory information for Bistos Infant Phototherapy Equipment (BT-450) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508275 and owned by Bistos Co., Ltd.. The device was registered on July 07, 2023.
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.
The infant phototherapy equipment, BT-450 is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home. The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10kg.