Continuous Positive Airway Pressure System for Neonates - Vietnam Registration 240000530/PCBB-HCM
Access comprehensive regulatory information for Continuous Positive Airway Pressure System for Neonates in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000530/PCBB-HCM and manufactured by Meditera Medical Device Manufacturing and Trading A.Ş.. The authorized representative in Vietnam is CÔNG TY TNHH DRAEGER VIỆT NAM.
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Device Details
Registration Details
240000530/PCBB-HCM
000.00.19.H29-240228-0029
Seattle PAP Plus
MP02260
Technical Details
Continuous Positive Airway Pressure (CPAP) system for neonates is designed to provide continuous positive airway pressure (nCPAP) through the nose to patients weighing up to 10 kg (22 lbs) and who are eligible for non-invasive respiratory support. The system is designed to be used with the Fisher and Paykel MR850 humidifier. The system is used in hospital environments, such as the Neonatal Intensive Care Unit (NICU) and the Pediatric Intensive Care Unit (PICU).
Dates and Status
Mar 11, 2024