Heyer Care Co.，Ltd.

Heyer Care Co., Ltd. specializes in respiratory therapy devices, specifically non-vented masks (such as the LuvRes F2NV and F1NV series) and nasal pillows masks (like the LuvOn P1). These devices are designed for continuous positive airway pressure (CPAP) and similar respiratory support applications, helping patients with conditions like sleep apnea.

Heyer Care Co., Ltd. is based in China. While the company’s location influences its regulatory obligations, its devices are classified as Class IIa under EU Medical Device Regulations (MDR), meaning they must comply with MDR requirements regardless of manufacturer origin. This classification determines the conformity assessment procedures and registration requirements, such as listing in the EU’s eudamed database.

Heyer Care Co., Ltd.’s devices are listed in the EU’s eudamed database. This registry is mandatory for Class IIa medical devices under the EU Medical Device Regulations (MDR), ensuring transparency and traceability of devices placed on the EU market. Listing confirms the device’s conformity assessment status and compliance with MDR requirements.

Heyer Care Co., Ltd.’s non-vented and nasal pillows masks are classified as Class IIa medical devices under the EU Medical Device Regulations (MDR). This classification is based on their intended use for respiratory support, where they pose a moderate risk to patients. Class IIa devices require a conformity assessment procedure, including clinical evaluation and technical documentation, to ensure safety and performance before market placement.