Quality Assurance & Safety

Made in Germany

We have always paid great attention to product safety and quality standards.

Quality and Safety

For over 45 years you can rely on the products of AGA Sanitätsartikel

All products, which are developed and produced exclusively in our main plant in Löhne, meet various German and European safety and quality standards. In order to ensure this, AGA Sanitätsartikel had already introduced a quality management system in 1995.

Since June 6, 2022, mdc medical device certification GmbH has certified that we have introduced and are using a quality management system for medical devices in accordance with DIN EN ISO 13485:2021, as well as requirements for regulatory purposes in the areas of development, manufacture and sale of medical furniture. The certification provided evidence that the quality management system meets the requirements of the aforementioned standard.

The current certificate has a validity until June 05, 2025.

CE Marking

Due to the introduced certified quality management system according to DIN EN ISO 13485:2021, we are authorized and may give our medical products the CE mark ourselves.

Declarations of conformity contain customer, product and order-related data. We can therefore only show you a sample declaration of conformity here. The marked places contain customer, product, shipping and order-related data upon delivery.

The corresponding declaration of conformity is enclosed with the shipment for each medical product. The type plates with the CE marking are attached to the medical device.

Our Benefits

  • Certified quality management system for medical products according to DIN EN ISO 13485:2022
  • CE marking
  • Spare parts deliveries for 10 years
  • Warranty obligation for 3 years
  • Maintenance-free products
  • Modular product range
  • Use of maintenance-free, splash-proof electric motors, specially shielded for cardiac pacemakers
  • Upholstery foam CFC free
  • Use of commercially available small parts (screws, ...)
  • Individual colour design

Our Services

  • Support and assistance with tenders and local product registrations
  • Planning and execution of national and international transports (with Atlas registration)
  • Planning and execution of deliveries "free german border" with disposal of the packaging material
  • Customer visits
  • Repairs
  • Implementation of individual customer requests
  • Supply of product images and text files
  • Variant productions / Custom products
  • Sales only via medical distributors

Questions? Contact us today!

Do you have questions about our products or services? Would like to get to know us? Contact us today, we will be pleased to provide expert advice tailored to your needs.