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Singapore HSA registration DE0509021

Bistos Infant Phototherapy Equipment BT-450

Singapore flagSingapore·CLASS B·Bistos Co., Ltd.·Registered March 04, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration information
Registration Number
DE0509021
Registration Date
March 04, 2024
Retention Due Date
March 03, 2026
Product description
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.
Product Owner
Name
Bistos Co., Ltd.
Short Name
Bistos Co., Ltd.
Address
7th Fl., A Bldg.,, Woolim Lions Valley 5-cha,, 302, Galmachi-ro, Jungwon-gu,, Seongnam-si, Gyeonggi-do, Korea., KOREA, REPUBLIC OF
Registrant
Name
Babylite Pte. Ltd.
Address
2 SINARAN DRIVE, SOLEIL @ SINARAN, #30-03, SINGAPORE 307467
Importer
Name
Babylite Pte. Ltd.
Address
2 Sinaran Drive, #30-03, SINGAPORE 307467
Model information
Model Name(s)
Infant Phototherapy Equipment Control box Pad
Model Identifier(s)
BT-450 BT-450 Control Box Pad
About this record

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 DE0509021 and owned by Bistos Co., Ltd.. The device was registered on March 04, 2024.

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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