Bariatric Solutions GmbH

Bariatric Solutions GmbH specializes in manufacturing calibration tubes, specifically designed for medical device testing and validation. These include variants like TUBE40Y, TUBE32W, TUBE38G, TUBE36B, and TUBE34R. These calibration tubes are used in bariatric surgery procedures, such as gastric banding and gastric bypass systems, to ensure proper sizing and functionality of associated medical devices during quality assurance and pre-procedural checks.

Bariatric Solutions GmbH is based in Switzerland. While the company operates within the Swiss market, its calibration tubes are designed to meet EU regulatory standards, including compliance with the EU Medical Device Regulation (MDR), particularly since these devices fall under Class I classification in the EU framework.

Yes, Bariatric Solutions GmbH’s calibration tubes are listed in the euDaMed database. This registry is part of the EU’s transparency framework for medical devices, ensuring visibility of manufacturers and their products under the EU Medical Device Regulation (MDR). Listing in euDaMed helps stakeholders verify the manufacturer and device details.

Bariatric Solutions GmbH’s calibration tubes are classified as Class I medical devices under the EU Medical Device Regulation (MDR). This classification applies because these products are intended for use in testing and validation procedures rather than direct patient treatment. Class I devices generally pose minimal risk and require less stringent regulatory oversight compared to higher-risk categories.