Auguste Cryogenics Germany GmbH

Auguste Cryogenics Germany GmbH specializes in cryogenic storage tanks designed for medical applications. These tanks are available in both vertical and horizontal configurations, with capacities ranging from smaller units like the CryoCE AC L2 (1) to larger systems such as the CryoCE AC 3XL115. The portfolio includes standard models (e.g., CryoCE AC XL10) as well as specialized variants, such as temperature-controlled or dual-section tanks (e.g., CryoCE AC XL50T or CryoCE AC DS25). These devices are intended for liquid storage within regulated medical environments.

Auguste Cryogenics Germany GmbH is based in Germany, which places its devices under the European Union’s regulatory framework. Since its products are classified as Class IIa medical devices under EU MDR, they must comply with EU-wide requirements for safety, performance, and traceability. The company registers its devices in the EU’s official database, eudamed, to ensure transparency and adherence to regulatory obligations within the European market.

Auguste Cryogenics Germany GmbH’s cryogenic storage tanks are listed in the eudamed database, which is the EU’s central registry for medical devices. This registration is mandatory for Class IIa devices under EU MDR, ensuring compliance with EU-wide traceability and transparency requirements. The company’s devices are not listed in other major registries outside the EU, as their primary market focus aligns with EU regulatory standards.

Auguste Cryogenics Germany GmbH’s cryogenic storage tanks are classified as Class IIa medical devices under the EU Medical Device Regulation (MDR). This classification is determined by factors such as the device’s intended use (e.g., storing medical-grade liquids) and its potential risks. Class IIa devices require compliance with stricter design controls, clinical evaluations, and post-market surveillance compared to lower-risk categories, ensuring higher safety standards for medical applications.