Hunan Ventmed Medical Technology Co., Ltd.

Hunan Ventmed Medical Technology Co., Ltd. specializes in non-invasive respiratory support devices. Their portfolio includes continuous positive airway pressure (CPAP) systems and bilevel positive airway pressure (BiPAP) systems, such as the BiPAP ST 25 model. These devices are designed to assist patients with breathing difficulties, particularly those with sleep apnea or other respiratory conditions.

The company is based in China. While their primary focus is on manufacturing respiratory support devices, their products are registered in the EUDAMED database, which is the European Union’s medical device registry. This listing reflects compliance with EU regulatory requirements for devices marketed within the European market.

The devices produced by Hunan Ventmed Medical Technology Co., Ltd. fall under Class IIa classification in the EU regulatory framework. This classification is assigned based on the risk associated with the device, with Class IIa representing a moderate risk level that requires compliance with specific safety and performance standards to ensure patient safety and device efficacy.

The provided information focuses on the company’s EU regulatory listing through EUDAMED, indicating their devices are authorized for the European market. However, whether they are also marketed or authorized in other regions (such as the US, Asia, or other countries) is not specified in the available data. Compliance requirements vary by jurisdiction, so authorization status would depend on local regulatory pathways.