Pure Global
Singapore HSA registration DE0500463

Bistos Ultrasound Fetal Doppler System

Singapore flagSingapore·CLASS B·Bistos Co., Ltd.·Registered September 19, 2016
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0500463
Registration Date
September 19, 2016
Retention Due Date
September 18, 2025
Product description
Bistos Fetal Doppler measures the fetal heart rate and projects the fetal heart’s sound through a built -in speaker. Measuring the fetal heart rate(FHR) gives an indication of the fetal’s well-being. This data is intended to aid in assessing the well-being of the fetus (Non-Stress Test). This device is for use only by trained medical personnel located in hospitals, clinics, doctor’s offices.
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
WALEN TEC ASIA PTE LTD
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Importer
Name
WALEN TEC ASIA PTE LTD
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #04-02, SINGAPORE 408734
Model information
Model Name(s)
Ultrasound Doppler System Ultrasound Doppler System Ultrasound Doppler System
Model Identifier(s)
BT200 BT220C BT220L
About this record

Access comprehensive regulatory information for Bistos Ultrasound Fetal Doppler 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 DE0500463 and owned by Bistos Co., Ltd.. The device was registered on September 19, 2016.

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