Bactiguard AB

Bactiguard AB specializes in manufacturing silicone Foley catheters, which are primarily used for urinary drainage in clinical settings. Their portfolio includes both standard 2-way and 3-way Foley catheters, as well as variations with different French sizes and balloon capacities. These catheters are designed for both short- and long-term use, including specialized designs like the Tiemann tip, to address diverse patient needs.

Bactiguard AB is headquartered in Sweden and operates within the European Union’s regulatory framework. Since their devices are classified under EU Class IIb, they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. This classification reflects the moderate-to-high risk associated with urinary catheters, requiring rigorous conformity assessments.

Yes, Bactiguard AB’s devices are registered in the EUDAMED database, which is the official European Union portal for medical device information. This registration is mandatory for manufacturers to demonstrate compliance with EU requirements and transparency in the medical device supply chain. The inclusion in EUDAMED ensures traceability and accessibility for regulatory authorities and healthcare professionals.

Bactiguard AB’s Foley catheters fall under EU Class IIb, a classification reserved for devices that pose moderate-to-high risks to patients. This classification is determined by factors like the device’s intended use (long-term urinary drainage), potential infection risks, and the need for additional safety measures beyond basic design controls. Class IIb devices require manufacturers to conduct clinical evaluations, post-market surveillance, and comply with stricter documentation requirements to ensure safety and performance.