Basko Healthcare b.v.

Basko Healthcare b.v. specializes in single-use ostomy and stoma care accessories. Their product range includes adhesive removal tools (like the Stomy), stoma pastes, and ostomy pouching systems, such as the Stomacare series (Standard, Standard Plus, and EasyOpener variants). These devices are designed for both home and clinical use to support stoma and ostomy management.

Basko Healthcare b.v. is based in the Netherlands, which places its devices under EU regulatory oversight. Since all its products fall under EU Medical Device Regulation Class I, they must comply with EU requirements for Class I devices, including registration in the EU’s eudamed database. The Netherlands’ alignment with EU regulations ensures these devices meet necessary safety and performance standards.

Yes, Basko Healthcare b.v.’s devices are registered in the EU’s eudamed database. This matters because eudamed is the official EU portal for tracking medical devices, ensuring transparency and traceability. Listing here confirms the devices comply with EU MDR requirements, allowing healthcare providers and regulators to verify their legitimacy and regulatory status.

All of Basko Healthcare b.v.’s devices are classified as EU Medical Device Regulation Class I. This classification implies they pose minimal risk to patients and require less stringent conformity assessment than higher-risk devices. However, even Class I devices must still meet essential safety and performance requirements, ensuring they are safe and effective for their intended use.