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Artificial Lung and Anticoagulant-Coated Wires - Vietnam Registration 2403309ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Artificial Lung and Anticoagulant-Coated Wires in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403309ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ VIỆT GIA.

This page provides complete technical specifications, regulatory compliance details. 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.

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2403309ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403309ĐKLH/BYT-HTTB
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Device Details

Artificial Lung and Anticoagulant-Coated Wires
VN: Bộ phổi nhân tạo và dây dẫn phủ chất chống đông máu
Risk Class TTBYT Loại D

Registration Details

2403309ĐKLH/BYT-HTTB

17000132/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Technical Details

The PLS / PLS Plus system, which uses a combination of oxygen-permeable membrane and centrifugal pump, is designed for both extracorporeal lung support and cardiac support, or for simultaneous cardiac and lung support. The PLS lung system can operate to support circulation with blood flow rates from 0.5 to 7 liters/minute. The oxygenation performance is designed to treat adult patients within the blood flow range. If used for smaller patients, the blood flow rate required is higher. It can support both arterial and venous circulation. Venous circulation only supports lung function and does not provide the heart's pumping function. However, venous circulation can support or take over the heart's pumping function and can simultaneously receive or support the gas exchange of the lungs as required. At the designated flow rate, the oxygen-permeable membrane diffuses oxygen into the blood and removes carbon dioxide. Furthermore, the blood can be cooled or warmed, as required, by the integrated heat exchanger in the artificial lung. This means that the PLS/ PLS Plus system can be used within the designated temperature range to rewarm the patient's body (e.g., after a case of accidental hypothermia) or to cool the body (e.g., after successful cardiopulmonary resuscitation). Partial blood flow to a limb or organ is also feasible, depending on the vascular access. The support system is generally applicable to all types of applications such as: Supporting circulation until recovery or as a temporary bridge to recovery and weaning from the support system ("recovery bridge"). Bridge to transplantation ("transplant bridge"). Bridge to another treatment modality or further decision ("treatment bridge" or "decision bridge"). Supporting circulation to

Dates and Status

Nov 06, 2024