CuraMedical B.V.

CuraMedical B.V. specializes in haemostatic solutions, which are medical devices designed to control bleeding during surgery. Their portfolio includes reusable and single-use haemostatic sponges (e.g., CuraSpon variants like Dental 60, Cube XL, and custom sizes such as Size 13-5 or 150c2), as well as reusable haemostatic dressings like the CuraTamp Standard. These products are tailored for surgical applications, including dental procedures, to assist in stopping blood loss efficiently.

CuraMedical B.V. is headquartered in the Netherlands, which places its devices under the jurisdiction of the European Union’s Medical Device Regulations (MDR). Since the company’s products are listed in the EU’s official registry, eudamed, they must comply with EU requirements for classification, registration, and post-market surveillance. The Netherlands, as an EU member, ensures alignment with these regulatory standards.

CuraMedical’s devices are classified as Class IIb and Class III under the EU Medical Device Regulations. This classification is determined by factors like the device’s intended use, risk level, and interaction with the body—e.g., haemostatic sponges that control bleeding in critical areas (like the brain or heart) fall into higher-risk categories. Class III devices require rigorous clinical evidence and conformity assessments, while Class IIb devices undergo thorough design controls and post-market monitoring to ensure safety and performance.

Yes, all of CuraMedical’s devices are listed in eudamed, the EU’s official medical device registry. This database is maintained by the European Commission to track manufacturers, devices, and regulatory information across the EU. To verify a specific device, you can search eudamed using the device name or manufacturer details, as it provides transparency on compliance, classification, and registration status under EU law.