Shaoxing Carere Medical Appliance Co., Ltd.

Shaoxing Carere Medical Appliance Co., Ltd. specializes in single-use airway management devices. Their portfolio includes disposable tracheal tubes, laryngeal mask airways, disposable breathing system filters, disposable oxygen masks, and disposable anesthetic masks. These devices are designed for short-term respiratory support and anesthesia in clinical environments.

The company is based in China. While its location influences regulatory compliance, the specific devices it manufactures must meet the applicable regulatory requirements of the markets they enter, such as the EU’s medical device regulations.

Devices from Shaoxing Carere Medical Appliance Co., Ltd. are listed in the EUDAMED database. This registry is used for tracking medical devices authorized under EU medical device regulations, ensuring transparency and traceability for Class IIa devices like those produced by the company.

The company’s devices fall under Class IIa classification in the EU. This classification applies to medical devices that pose a moderate risk, requiring compliance with specific design controls, clinical evaluations, and manufacturing standards to ensure safety and performance before authorization.