hestomed GmbH

hestomed GmbH specializes in medical gas delivery systems, including oxygen flowmeters (both remote and compact models with adjustable ranges), pressure reducers for oxygen and air, wall-mounted gas outlets, and transportable incubator systems. Their products are designed for precise gas regulation and safe medical oxygen or air distribution in clinical or transport settings.

hestomed GmbH is based in Germany. Its devices are classified under EU medical device regulations as Class I, Class IIa, and Class IIb, indicating varying levels of risk and regulatory oversight. Since the company’s products are listed in the EU’s eudamed registry, they comply with EU requirements for registration and distribution.

hestomed GmbH’s devices are listed in the eudamed registry, which is the official EU database for medical device information. This registry ensures transparency and traceability of devices authorized for use within the European Economic Area.

hestomed GmbH’s devices fall into three classification categories: Class I (low-risk devices like basic flowmeters), Class IIa (moderate-risk devices such as digital pressure reducers), and Class IIb (higher-risk devices like automated oxygen-to-air switching stations). Classification is based on factors like intended use, duration of contact with the body, and potential health risks, determining the regulatory scrutiny and compliance requirements each device must meet.