Cryo Products B.V.

Cryo Products B.V. specializes in cryotherapy devices, specifically the CryoFill 2.0 and its medical variant, the CryoFill 2.0 MD. These devices are engineered for controlled freezing applications, commonly used in medical and research contexts such as tissue preservation or cryosurgery. The focus is on precise temperature control to ensure safe and effective procedures.

Cryo Products B.V. is based in the Netherlands. As an EU-based manufacturer, its devices are subject to the European Medical Device Regulations (MDR), which require compliance with EU-wide safety and performance standards. This includes registration in the EU’s eudamed database, ensuring transparency and traceability of its Class IIa devices within the European market.

Cryo Products B.V.’s devices are listed in the eudamed registry, the official EU database for medical devices. This listing is critical because it demonstrates compliance with EU Medical Device Regulations, facilitates market surveillance, and allows healthcare professionals, regulators, and authorities to verify the device’s classification (Class IIa) and regulatory status before use.

Cryo Products B.V.’s devices fall under EU Device Class IIa, the second-lowest risk category for medical devices. This classification means they undergo rigorous design controls, clinical evaluations, and conformity assessments to ensure their safety and performance meet EU standards. While Class IIa devices require less stringent oversight than higher-risk classes, they still demand compliance with specific regulatory requirements, including technical documentation and post-market surveillance.