Singapore HSA registration DE0507810
BMC G3 BPAP System
Singapore·CLASS C·BMC Medical Co,. Ltd.·Registered February 22, 2023Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0507810
- Registration Date
- February 22, 2023
- Retention Due Date
- February 21, 2026
Product description
The G3 B20A / B25S / B25A / B25VT / 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. The devices are intended for adult patients by prescription in the home or hospital/institutional environment. The G3 LAB BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation treatment and titration for patients with Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), Mixed Sleep Apnea (MSA), periodic breathing and Respiratory Insufficiency. The device is intended for adult patients by prescription in a clinical environment. The optional SpO2 kit 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, 100036 Beijing, CHINA
Registrant
- Address
- 116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
- Address
- 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088 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 Full Face Mask Full Face Mask Full Face Mask Full Face Mask BPAP System BPAP System BPAP System BPAP System BPAP System BPAP System Breathing Tube Breathing Tube Heated Tubing Nasal Mask Nasal Mask Nasal Mask Nasal Mask Nasal Mask Nasal Mask Nasal Mask Nasal Mask Nasal Mask Nasal Mask SpO2 Kit Wifi-Kit
- Model Identifier(s)
- F5 (all size kit) F5 (large) F5 (medium) F5 (small) F5A (all size kit) F5A (large) F5A (medium) F5A (small) G3 B20A G3 B25A G3 B25S G3 B25VT G3 B30VT G3 LAB L1(D15) L1(D19) LH1 N5 (all size kit) N5 (extra large) N5 (large) N5 (medium) N5 (small) N5A (all size kit) N5A (extra large) N5A (large) N5A (medium) N5A (small) SP-100 WL-500
About this record
Access comprehensive regulatory information for BMC G3 BPAP System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507810 and owned by BMC Medical Co,. Ltd.. The device was registered on February 22, 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.
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