Varialux GmbH

Varialux GmbH Overview

Varialux GmbH is a medical technology company based in Bautzen, Sachsen. The company develops, produces or distributes medical devices, instruments or systems for use in healthcare facilities.

Products & Solutions

Varialux GmbH, as a medical technology company, offers solutions for medical facilities, hospitals and practices. All products must meet the requirements of the EU Medical Device Regulation (MDR 2017/745) and bear the CE marking.

Location & Contact

Varialux GmbH can be reached at the following address: Kleinwolmsdorfer Strasse 16, 01477 Bautzen. For current information and enquiries, please contact the organisation directly.

More information: Medizintechnik in Sachsen or all Medizintechnik in Germany on Sanoliste.

Medizinprodukte-Regulierung (MDR)

Medizintechnikunternehmen wie Varialux GmbH have been required to comply with the EU Medical Device Regulation (MDR 2017/745) since May 2021, which has significantly raised the requirements for clinical evidence, post-market surveillance and traceability compared to the previous Medical Devices Directive (MDD). The regulation requires the unique identification of every medical device via the Unique Device Identification (UDI) system and registration in the European database EUDAMED.

Branche & Marktumfeld

With over 250,000 employees and a revenue of approximately 38 billion euros, the German medical technology sector is among the most innovative industries. Varialux GmbH in Bautzen is part of this ecosystem. Germany is the third-largest medical technology market worldwide after the USA and China. Over 90 per cent of the approximately 1,500 medical technology companies are small and medium-sized enterprises (SMEs), which are often leaders in specialised niches.

Qualitätsmanagement & Zertifizierung

For the manufacturing and distribution of medical devices, a quality management system in accordance with ISO 13485 is standard practice in the industry. The standard defines requirements for the development, production, installation and maintenance of medical devices. In addition, the MDR requires comprehensive technical documentation, clinical evaluations and systematic risk management in accordance with ISO 14971 throughout the entire product lifecycle.