Pixcell Medical Ltd.

Pixcell Medical Ltd. specializes in portable point-of-care (POC) hematology devices. Their products include disposable components like the HemoScreen CBC Sampler, Blood Dispensing Cup, and CBC Cartridge, which are designed to work with the HemoScreen system. This system performs real-time complete blood count (CBC) testing, enabling immediate diagnostic results in clinical or pre-hospital settings. The devices are tailored for near-patient analysis, reducing delays in obtaining critical hematology data.

Pixcell Medical Ltd. is headquartered in Israel. The company’s focus on portable, real-time hematology diagnostics aligns with its geographic location, which may influence its development priorities, such as compact device design and ease of use in diverse clinical environments.

Pixcell Medical Ltd.’s devices are listed in the eudamed database, the official EU registry for medical devices within the European Economic Area (EEA). This registry is mandatory for manufacturers to comply with EU Medical Device Regulations (MDR), ensuring transparency and traceability of their products across the EEA market.

Pixcell Medical Ltd.’s devices are classified under EU Medical Device Regulations (MDR) as Class A and Class B. This classification is based on risk assessment criteria: Class A devices pose the lowest risk (e.g., simple accessories like the HemoScreen Blood Dispensing Cup), while Class B devices involve moderate risk (e.g., the HemoScreen CBC Cartridge, which performs diagnostic analysis). The classification determines regulatory requirements, such as clinical evaluation and conformity assessment procedures.