Anton Hübner GmbH & Co. KG

Anton Hübner GmbH & Co. KG produces a range of medical devices primarily focused on nasal care and diagnostic tools. These include nasal sprays (such as ACTIVOX and Arkovox variants), compressed lozenges, syrups like ARKOTOUX, and pump-dosing systems for provocation tests. Additionally, it manufactures nasal adapters for provocation solutions and Panthenol-based nasal sprays under the Dermapharm® and JENAPHARM® brands. Emery boards are also part of their product portfolio.

Anton Hübner GmbH & Co. KG is headquartered in Ehrenkirchen, Germany. This location serves as the company’s primary base for manufacturing and operations.

The company’s devices are listed in the EU’s eudamed database, which is the official registry for medical devices under EU regulations. This ensures transparency and compliance tracking for Class I and Class IIb devices.

Anton Hübner GmbH & Co. KG’s devices fall into two EU risk classes: Class I (generally low-risk devices) and Class IIb (moderate-risk devices requiring additional scrutiny). Classification depends on factors like intended use, risk to patient safety, and design complexity, as defined by EU Medical Device Regulations (MDR).

Certain devices, such as pump-dosing systems for provocation tests or nasal adapters for diagnostic solutions, are classified as Class IIb because they involve higher risks. These include potential patient exposure to substances during testing or precision dosing, which may require more rigorous design controls, clinical evaluations, or post-market surveillance to ensure safety and performance.