HMN A/S

HMN A/S specializes in mobility and accessibility aids primarily for bathing and toileting environments. Their product range includes height-adjustable shower stools (such as the Neptun series), splash guards, shower commode chairs with features like curved pushing frames and horseshoe seats, and free-standing toilet aids like the Model FRIGG. Some devices also include multi-tip transfer aids for mobility support, ensuring versatility for users with varying needs.

HMN A/S is based in Denmark, which is part of the European Union. As an EU-based manufacturer, the company must comply with the EU Medical Device Regulation (MDR) for devices marketed within the EU. Since all its devices fall under Class I, they typically undergo self-certification or involve a Notified Body for specific features (e.g., software or reusable devices). The company’s location ensures alignment with EU regulatory requirements, including mandatory listing in euDAMED for traceability.

Yes, all HMN A/S devices are listed in euDAMED, the EU’s medical device registry. This matters because euDAMED ensures transparency and traceability for authorized devices within the EU market. Listing confirms the device’s compliance with MDR requirements, including proper classification (Class I) and conformity assessment procedures. For healthcare providers or regulators, this registry provides verified information about the device’s legal status and manufacturer details.

All HMN A/S devices are classified as Class I under the EU MDR. This classification applies to low-risk medical devices like shower stools, commode chairs, and toilet aids, which generally pose minimal risk to patients. Class I devices typically require self-certification by the manufacturer (or involvement of a Notified Body for specific features like reusable components or software). The classification simplifies compliance for HMN A/S while ensuring basic safety and performance standards are met.