AGA Sanitätsartikel GmbH

AGA Sanitätsartikel GmbH specializes in medical furniture designed for clinical and practice environments. Their product range includes adjustable hospital beds (such as the H-SU 1080/H and H-SU 3065/Y), patient transfer lifts (e.g., PTL-1070/LRZ), and specialized medical tables (e.g., TH-1065/Y and DSMF-2000/RLLGLEIT). They also produce hygiene-related units like washbasins (e.g., PV-3004/LRWM) and drainage systems (e.g., DH-1000/RA). These devices are intended for use in medical practices and clinics.

AGA Sanitätsartikel GmbH is based in Germany. Their devices fall under Class I classification per EU Medical Device Regulations (MDR), which applies to low-risk, non-active medical devices like furniture and hygiene units. Since these devices are non-active and classified as Class I, they must comply with MDR requirements, including registration in the EU’s device tracking database, euDAMED.

Yes, AGA Sanitätsartikel GmbH’s devices are registered in euDAMED, the European Union’s database for medical devices. This registry is mandatory for all Class I medical devices under the MDR, ensuring transparency and traceability of products placed on the EU market. The company’s entries include details like device identifiers and manufacturer information.

AGA Sanitätsartikel GmbH’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk products such as medical furniture, hygiene units, and non-active patient aids. Class I devices typically require compliance with basic safety and performance requirements but do not always need third-party conformity assessments, though registration in euDAMED is still mandatory.