Non-invasive Ventilation Machine
- Analysis ID
- 240001924/PCBB-HCM
- Submission ID
- 000.00.19.H29-240821-0001
- Product Type
- Lumis 150 VPAP ST
- Manufacturer
- ResMed Pty Ltd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- ResMed Pty Ltd
- Authorized Representative
- CÔNG TY TNHH ASIA ACTUAL VIETNAM
- Intended Use
- It is designated to provide non-invasive ventilation aimed at treating respiratory failure or obstructive sleep apnea (OSA) in patients weighing more than 13 kg or more than 30 kg in the iVAPS mode. The device is designed for use at home and in the hospital. The humidifier is designed for personal use by patients at home and for reuse in the hospital or facility.
- Registration Date
- Aug 26, 2024
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Access comprehensive regulatory information for Non-invasive Ventilation Machine 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 240001924/PCBB-HCM and manufactured by ResMed Pty Ltd. The authorized representative in Vietnam is CÔNG TY TNHH ASIA ACTUAL VIETNAM.
This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Hunan VentMed Medical Technology Co., Ltd, Theo theo phụ lục, and 3 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.