Coloplast GmbH

Coloplast GmbH Overview

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

Products & Solutions

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

Location & Contact

Coloplast GmbH can be reached at the following address: Kuehnstraße 75, 22045 Hamburg – Phone: 0800780900. For current information and enquiries, please contact the company directly.

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

Medizinprodukte-Regulierung (MDR)

Since May 2021, medical technology companies like Coloplast GmbH have had to comply with the EU Medical Devices Regulation (MDR 2017/745), which sets significantly stricter requirements for clinical assessments, traceability and post-market surveillance than the previous directive. All medical devices require CE marking by a notified body and must be registered in the European database EUDAMED.

Branche & Marktumfeld

The German medical technology industry is one of the most innovative industries with over 250,000 employees and a turnover of around 38 billion euros. Coloplast GmbH in Hamburg is part of this ecosystem. Germany is the third largest medical technology market in the world after the USA and China. Over 90 percent of the approximately 1,500 medical technology companies are small and medium-sized companies (SMEs), which are often leaders in specialized niches.

Qualitätsmanagement & Zertifizierung

A quality management system in accordance with ISO 13485 is standard practice in the industry for the production and sale of medical devices. The standard defines requirements for the development, production, installation and maintenance of medical devices. In addition, the MDR requires extensive technical documentation, clinical assessments and systematic risk management according to ISO 14971 over the entire product life cycle.