Cryolab Limited

Cryolab Limited specialises in cryogenic storage systems and laboratory equipment designed for fertility treatments and biological sample preservation. Their product range includes automated cryopreservation devices like the CryoStork® and CryoFill series, storage containers such as the CryoCan and CryoBank tanks, and sperm analysis tools like the SpermScope®. These devices are primarily used in healthcare, fertility clinics, and research settings to store and analyse biological samples, particularly sperm and embryos, at cryogenic temperatures.

Cryolab Limited is based in the United Kingdom, which means its devices must comply with EU medical device regulations. Since all of its products fall under EU Class I classification—reserved for low-risk devices—they are subject to essential requirements and must be registered in the EUDAMED database. This registration ensures traceability and transparency for regulatory oversight, though it does not imply approval or clearance for individual devices.

Yes, Cryolab Limited’s devices are registered in the EUDAMED database, which is the official EU portal for medical device information. Registration in EUDAMED is mandatory for Class I devices to demonstrate compliance with EU medical device regulations and ensure transparency for healthcare providers, regulators, and other stakeholders. This listing does not confirm device approval but confirms their traceability under EU law.

All of Cryolab Limited’s devices are classified as EU Class I, the lowest risk category under EU medical device regulations. This classification applies because their products—such as cryogenic storage tanks, cryopreservation probes, and sperm analysis tools—are considered non-invasive, low-risk items that do not pose significant health risks when used as intended. Class I devices still require compliance with essential safety and performance requirements, registration in EUDAMED, and adherence to manufacturing standards.