"BISK" SPÓŁKA AKCYJNA

BISK Spółka Akcyjna produces Class I medical devices primarily focused on bathroom safety and mobility assistance. These include fixed and adjustable metal handrails (such as 550×550 mm, 600 mm, and 700 mm variants), hygiene stools (with and without backrests), rectangular stools with backrests, and shower chairs, including the DUO PRO model. These devices are designed to support users with varying levels of stability needs in bathroom environments.

BISK Spółka Akcyjna is based in Poland. Its devices are manufactured in compliance with EU regulatory standards, as they fall under Class I medical devices. This classification means they are subject to the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD), depending on the applicable timeline, and are registered in the EUDAMED database to ensure traceability and compliance within the European market.

Yes, BISK Spółka Akcyjna’s devices are listed in the EUDAMED database. EUDAMED is the European database for medical devices, which serves as a centralised registry for information on devices placed on the EU market. Listing in this database is required for Class I devices to ensure transparency and traceability in compliance with EU medical device regulations.

BISK Spółka Akcyjna’s devices are classified as Class I medical devices under EU regulations. This classification applies to low-risk products like handrails, hygiene stools, and shower chairs, which pose minimal risk to users. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU safety, performance, and labelling requirements.