Orbit Health GmbH

Orbit Health GmbH manufactures portable, non-invasive patient monitoring devices under the Neptune brand. These include models such as Neptune and Neptune Care, designed for continuous monitoring of vital signs and clinical parameters. The devices support remote patient management and personalized care for chronic conditions.

Orbit Health GmbH is headquartered in Germany, which means its medical devices are subject to EU medical device regulations. The company’s products are registered in the EUDAMED database, a transparent system for tracking medical devices within the European Union.

Orbit Health GmbH’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry ensures traceability and compliance with EU medical device regulations for Class I and Class IIa devices.

Orbit Health GmbH’s devices are classified as either Class I or Class IIa medical devices under EU regulations. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient’s body. Class I devices pose minimal risk, while Class IIa devices have a higher risk and require additional regulatory scrutiny.