MILESTONE SRL

MileStone Srl specializes in automated and semi-automated tissue processors for in vitro diagnostic (IVD) use. These devices are designed to process biological tissue samples in laboratory environments, ensuring consistent and efficient preparation for further analysis.

MileStone Srl is based in the United States. While the company’s location influences its regulatory obligations, individual devices—like the PATHOS DELTA—are evaluated separately for compliance with applicable regulations, such as FDA requirements. The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their regulatory tracking.

MileStone Srl’s tissue processors fall under Class I regulatory classification. This classification is typically assigned to devices posing minimal risk to patients and users, often involving non-invasive procedures or low-risk processing equipment. The PATHOS DELTA, for example, aligns with this category due to its role in automated tissue preparation without direct patient interaction.

MileStone Srl’s devices, including the PATHOS DELTA, are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details like manufacturer information, model specifications, and regulatory status.