Pure Global

BMC G2S Series CPAP System - HSA Registration DE0510170

Access comprehensive regulatory information for BMC G2S Series CPAP 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 DE0510170 and owned by BMC Medical Co,. Ltd.. The device was registered on December 19, 2024.

This page provides complete registration details including product owner information, registrant details, 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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0510170
BMC G2S Series CPAP System
HSA Registration Number: DE0510170
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The G2S A20 / G2S C20 system is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only, either in the hospital or at home. The device is to be used only on the instruction of a licensed health care professional. Your home care provider will make the correct pressure settings according to your health care professionalโ€™s prescription.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0510170
Registration Date
December 19, 2024
Retention Due Date
December 18, 2025
Product Owner
Short Name
BMC Medical Co,. Ltd.
Address
Room 110 Tower A Fengyu Building, No. 115 Fucheng Road, Haidian, 100036 Beijing, CHINA
Registrant
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Model Information
Model Name(s)
Auto CPAP System CPAP System Breathing Tube Breathing Tube SpO2 & GPRS Kit SpO2 Kit WiFi Kit Cellular Module(2G) Cellular Module(4G)
Model Identifier(s)
G2S A20 G2S C20 L1(D15) L1(D19) SG-200 SK-21A WL-100 WL-200 WL-300