Pure Global
Singapore HSA registration DE0508275

Bistos Infant Phototherapy Equipment (BT-450)

Singapore flagSingapore·CLASS B·Bistos Co., Ltd.·Registered July 07, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Obstetrics & Gynaecology
Registration information
Registration Number
DE0508275
Registration Date
July 07, 2023
Retention Due Date
July 06, 2025
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
7thFl.,A Bldg.,Woolim Lions Valley, 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea, KOREA, REPUBLIC OF
Registrant
Name
CAPSULE PHARMA PTE. LTD.
Address
1 KAKI BUKIT ROAD 1, ENTERPRISE ONE, #02-44, SINGAPORE 415934
Importer
Name
CAPSULE PHARMA PTE. LTD.
Address
160 PAYA LEBAR ROAD, ORION @ PAYA LEBAR, #05-03, SINGAPORE 409022
Model information
Model Name(s)
Bistos Infant Phototherapy Equipment (BT-450)
Model Identifier(s)
BT-450
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 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B