Hangzhou HealthSky Biotechnology Co., Ltd.

Hangzhou HealthSky Biotechnology Co., Ltd. specializes in automated cytology workstations, including fully automated liquid-based cytology systems like the PSS-160B, PSS-320B, and PSS-480A. These systems are designed to process and analyze cytological samples, streamlining diagnostic workflows in pathology labs. The company also produces standalone devices such as the PSS-05A, PSS-120B, and PSS-80B, as well as specialized tools like the Healthsky system and the DE-LIN device, which likely assist in sample preparation or analysis.

The company is headquartered in China, specifically in Hangzhou. Its location influences its regulatory compliance requirements, particularly for medical devices intended for domestic or international markets, though regulatory status depends on individual device authorizations.

The company’s devices are listed in the euDaMed database, which is the official European Union registry for medical devices. This inclusion indicates compliance with EU regulatory requirements for device traceability and transparency, though individual devices must still undergo their own authorization processes.

All listed devices from Hangzhou HealthSky Biotechnology Co., Ltd. fall under Class A classification in the EU regulatory framework. This classification applies to devices posing minimal risk, such as automated cytology workstations, which typically require less stringent pre-market evaluation compared to higher-risk devices. Classification is determined by factors like intended use and potential harm.