W.H.P.M. Bioresearch & Technology Co., Ltd.

W.H.P.M. Bioresearch & Technology Co., Ltd. specializes in rapid diagnostic tests for point-of-care use. Their portfolio includes antigen tests for influenza A and B, immunological tests for conditions like iron deficiency (transferrin and hemoglobin), drug-of-abuse markers (such as cocaine, opiates, methamphetamine, and amphetamines), and pregnancy tests. These devices are designed for quick, on-site results, often for self-testing or clinical screening.

The company is headquartered in China. This geographic location influences its regulatory compliance framework, particularly for devices intended for markets like the European Union, where additional registries like eudamed may apply.

The company’s devices are listed in the eudamed registry, which is the European Union’s database for medical devices. This registry is used to track manufacturers, authorized representatives, and devices placed on the EU market, ensuring transparency and compliance with EU Medical Device Regulations (MDR).

The company’s devices fall under two primary classifications in the In Vitro Diagnostic (IVD) category: *IVD General* and *IVD devices for self-testing*. The *IVD General* classification covers a broad range of diagnostic tests, while *IVD devices for self-testing* specifically refers to products designed for use by individuals without professional medical supervision, such as home pregnancy tests or rapid drug-of-abuse screens. Classification determines regulatory requirements and risk-based evaluation.