AEROPHARM GmbH

AEROPHARM GmbH specializes in manual, syringe-loaded injectors designed for home use. These devices are intended to help patients administer medications or vaccines independently, such as the Glatopaject® injector. The focus is on simplifying self-injection procedures for users.

AEROPHARM GmbH operates from the United States. The company’s headquarters and manufacturing operations are located within the country, though specific regional offices or facilities may vary.

AEROPHARM GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices under FDA oversight, including classification and identification details.

AEROPHARM GmbH’s devices fall under the FDA’s Class II regulatory category. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.