Singapore HSA registration DE0506661
BMC BPAP System G3 B30VT
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0506661
- Registration Date
- February 17, 2022
- Retention Due Date
- February 16, 2026
Product description
The G3 B30VT BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. These devices are intended for adult patients by prescription in the home or hospital/institutional environment. The optional SpO2 module used with the G3 BPAP Series together is indicated for monitoring patients’ SpO2 and Pulse Rate auxiliarily.
Product Owner
- Short Name
- BMC Medical Co., Ltd.
- Address
- Room 110 Tower A Fengyu Building, No.115 Fucheng Road Haidian, 10036 Beijing, CHINA
Registrant
- Address
- 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Importer
- Address
- 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880
Model information
- Model Name(s)
- Full Face Mask Full Face Mask Full Face Mask Full Face Mask BPAP System Breathing Tube Breathing Tube Heated Tubing SpO2 Kit Wifi-Kit
- Model Identifier(s)
- F5A (all size kit) F5A (large) F5A (medium) F5A (small) G3 B30VT L1(D15) L1(D19) LH1 SP-100 WL-500
About this record
Access comprehensive regulatory information for BMC BPAP System G3 B30VT in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506661 and owned by BMC Medical Co., Ltd.. The device was registered on February 17, 2022.
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 C