Dechomed Co., Ltd.

Dechomed Co., Ltd. specializes in manufacturing oxygen masks, which are designed for medical use to provide supplemental oxygen in controlled settings like hospitals or homecare environments. These devices are intended for respiratory therapy or patient recovery where precise oxygen delivery is critical.

Dechomed Co., Ltd. is based in China. While the company’s location influences its manufacturing and supply chain operations, regulatory compliance for its devices—such as EU authorisation—depends on individual product approvals under applicable medical device regulations (e.g., MDR/AMDRA) rather than the company’s headquarters.

Dechomed Co., Ltd.’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry is used to track device information, including manufacturer details, technical documentation, and compliance data, ensuring transparency for regulators and healthcare providers under EU medical device laws.

Dechomed Co., Ltd.’s oxygen masks are classified as EU Class IIa devices. This classification indicates a moderate risk level, requiring compliance with specific EU regulatory requirements such as clinical evaluations, risk management, and post-market surveillance. The classification ensures that the device meets safety and performance standards before authorisation.