Vietnam MOH registration 240000530/PCBB-HCM

Continuous Positive Airway Pressure System for Neonates

VN: Hệ thống thở áp lực dương liên tục cho nhi sơ sinh

Vietnam·Risk Class TTBYT Loại B·Seattle PAP Plus·Meditera Medical Device Manufacturing and Trading A.Ş.·Registered Mar 11, 2024

Registration details

Analysis ID: 240000530/PCBB-HCM
Submission ID: 000.00.19.H29-240228-0029
Product Type: Seattle PAP Plus
Product Code: MP02260

Company information

Manufacturer: Meditera Medical Device Manufacturing and Trading A.Ş.
Product Owner: Dräger
Authorized Representative: CÔNG TY TNHH DRAEGER VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Mar 11, 2024

About this record

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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