Vietnam MOH registration 240001587/PCBB-HCM

Machine for diagnosing sleep apnea

VN: Máy chẩn đoán chứng rối loạn nhịp thở khi ngủ

Vietnam·Risk Class TTBYT Loại B·ApneaLink Air·ResMed Pty Ltd·Registered Jul 26, 2024

Registration details

Analysis ID: 240001587/PCBB-HCM
Submission ID: 000.00.19.H29-240723-0004
Product Type: ApneaLink Air

Company information

Manufacturer: ResMed Pty Ltd
Product Owner: ResMed Pty Ltd
Authorized Representative: CÔNG TY TNHH ASIA ACTUAL VIETNAM

Technical details

Intended Use: The ApneaLink Air device is intended for Healthcare Professionals (HCP) to be able to support the diagnosis of sleep disordered breathing in adult patients. ApneaLink Air records the following data: the patient's nasal airflow, snoring sounds, blood oxygen saturation, and respiratory efforts during sleep. The device uses these recordings to generate a report for the HCP to support the diagnosis of sleep disordered breathing or for additional clinical investigation, if possible. The device is designed to be used at home and in the hospital under the guidance of the HCP.

Dates and status

Registration Date: Jul 26, 2024

About this record

Access comprehensive regulatory information for Machine for diagnosing sleep apnea 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 240001587/PCBB-HCM and manufactured by ResMed Pty Ltd. The authorized representative in Vietnam is CÔNG TY TNHH ASIA ACTUAL VIETNAM.

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