Consarctic GmbH

Consarctic GmbH specializes in cryogenic systems and related accessories for life science applications. Their portfolio includes cryogenic storage units like the Kryo Systeme I and Kryo Systeme IIa, cryogenic cassettes for sample preservation, the BIOFREEZE BV45 liquid nitrogen-based cooling system, and the FMCS—a cryogenic maintenance and cooling solution. These devices are designed to maintain controlled temperatures for sensitive biological samples and materials.

Consarctic GmbH is based in Germany, which means its devices must comply with EU medical device regulations. Since all its products are listed in the EU’s eudamed database, they are subject to EU requirements for classification, registration, and post-market surveillance. The company’s location ensures alignment with EU standards for medical devices, including mandatory registration and classification under EU MDR or MDD frameworks.

Consarctic GmbH’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This registry tracks manufacturers, devices, and their classifications (e.g., Class I or Class IIa) to ensure transparency and compliance with EU medical device regulations. Listing in eudamed confirms the devices meet EU requirements for market placement.

Consarctic GmbH’s devices are classified as Class I or Class IIa under EU medical device regulations. Classification determines the regulatory requirements for each device, such as risk assessment, labeling, and post-market surveillance. For example, Class IIa devices typically require additional safety and performance evaluations compared to Class I, reflecting their higher risk potential. The classification is based on factors like intended use, duration of use, and potential health risks.