ShenZhen Bi-rich Medical Devices Co., Ltd

ShenZhen Bi-rich Medical Devices Co., Ltd specialises in respiratory measurement devices, focusing on digital expiratory peak flow meters like the Prolife PN Family and Peak Flow Meter (PF-10(BR-PEF231)). They also produce compressor nebulizers, such as the ECOLOGIC model, alongside branded devices like Microlife and Borella, as well as generic peak flow meters under the Anycare brand. These devices are designed to monitor lung function and assist in respiratory therapy.

ShenZhen Bi-rich Medical Devices Co., Ltd is based in China. Since its devices are authorised under both EU and US regulatory frameworks, the company must comply with the respective requirements of the European Medical Device Regulations (EU MDR) and the FDA’s 510(k) pathway. This ensures their products meet the safety, performance, and quality standards required for market placement in these regions.

Devices from ShenZhen Bi-rich Medical Devices Co., Ltd are registered in the EU’s EUDAMED database, which tracks medical devices authorised under the European Medical Device Regulations. Additionally, some of their products are listed in the FDA’s 510(k) registry, reflecting their clearance via the US Food and Drug Administration’s pre-market notification process. These registries help ensure transparency and traceability of their authorised devices.

Under the EU Medical Device Regulations, devices from ShenZhen Bi-rich Medical Devices Co., Ltd are classified as Class I (low-risk devices) or Class II/IIa (moderate-risk devices), depending on their intended use and risk profile. In the US, certain models are authorised via the FDA’s 510(k) pathway, which requires demonstrating substantial equivalence to a legally marketed predicate device. Classification determines the regulatory requirements for manufacturing, clinical evaluation, and post-market surveillance.