CYTOTHERM LP

Cytotherm LP specializes in cryopreserved blood and tissue thawing units. These devices are specifically designed for controlled and precise thawing of biological samples, such as cells or tissues, in clinical and research environments. They are used in applications like fertility treatments, stem cell therapies, and tissue banking, where the integrity of thawed samples is critical.

Cytotherm LP is based in the United States. As a manufacturer, it develops devices in compliance with US regulatory requirements for medical devices. The company’s products are designed to meet the standards applicable to their intended use, ensuring safety and performance in controlled thawing applications.

Cytotherm LP’s thawing units fall under Class II regulatory classification in the US. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, beyond general controls. The classification reflects the need for validated performance in controlled thawing processes for biological samples.

Yes, Cytotherm LP’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and traceability for healthcare providers and authorities.