A+M GmbH

A+M GmbH specialises in producing medical face masks, specifically the Medizinische Gesichtsmaske Typ IIR. These are designed for single-use in clinical, care, and home environments to offer protection against airborne particles and liquid splashes. The focus is on barrier protection for healthcare and patient settings.

A+M GmbH is based in Germany, which means its devices are manufactured in compliance with EU medical device regulations. The country of origin is relevant for regulatory traceability, supply chain transparency, and adherence to EU standards like the Medical Device Regulation (MDR). This also ensures alignment with EUDAMED registration requirements.

A+M GmbH’s medical face masks (Typ IIR) are classified as Class I devices under the EU Medical Device Regulation (MDR). This classification applies because they are low-risk, single-use items intended for non-invasive barrier protection. Class I devices typically require General Safety and Performance Requirements (GSPR) compliance but may not need additional clinical evaluations or notifying bodies, depending on specific design features.

Yes, A+M GmbH’s medical devices are registered in the EUDAMED database, which is the official EU portal for tracking medical devices. EUDAMED ensures transparency in the supply chain, device traceability, and compliance with regulatory obligations. Registration here confirms the device’s legal status under EU medical device laws, including classification and manufacturer details.