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Singapore HSA registration DE0505098

BMC BPAP System

Singapore flagSingapore·CLASS B·BMC Medical Co., Ltd.·Registered November 03, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0505098
Registration Date
November 03, 2020
Change Notification Approval Date
April 26, 2021
Retention Due Date
November 02, 2025
Product description
The G3 B30SV 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), Central Sleep Apnea (CSA), Mixed Sleep Apnea (MSA), and periodic breathing. The G3 B25A 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).
Product Owner
Name
BMC Medical Co., Ltd.
Short Name
BMC Medical Co., Ltd.
Address
Room 110 Tower A Fengyu Building, No. 115 Fucheng Road Haidian, 100036 Beijing, CHINA
Registrant
Name
WE ARE MEDBITZ PTE LTD
Address
111 SOMERSET ROAD, 111 SOMERSET, #04-26, SINGAPORE 238164
Importer
Name
WE ARE MEDBITZ PTE LTD
Address
111 SOMERSET ROAD, 111 SOMERSET, #04-26, SINGAPORE 238164
Model information
Model Name(s)
Full Face Mask Full Face Mask Full Face Mask Full Face Mask BPAP System BPAP System Breathing Tube Breathing Tube Heated Tubing Nasal Mask Nasal Mask Nasal Mask Nasal Mask P2 Nasal Pillows Interface SpO2 Kit
Model Identifier(s)
F5 (all size kit) F5 (large) F5 (medium) F5 (small) G3 B25A G3 B30SV L1(D15) L1(D19) LH1 N5A (extra large) N5A (large) N5A (medium) N5A (small) P2 SP-100
About this record

Access comprehensive regulatory information for BMC BPAP 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 DE0505098 and owned by BMC Medical Co., Ltd.. The device was registered on November 03, 2020.

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