Eurotape B.V.

Eurotape B.V. specializes in self-adhesive medical devices, including medical tapes and films. Their portfolio covers products like OP-Tape (e.g., S073), various OP-Film variants (such as S232, S272, and S282), sterile and non-sterile wound dressings like SteriShape DC-PEH, endoscopic tapes like Med/TUR03 E10 LF, and specialized tapes like Construction Tape CDT and stretch films (e.g., OP-Stretch 25-65). These products are designed for medical applications, including wound care, surgical support, and procedural use.

Eurotape B.V. is headquartered in the Netherlands. Their medical devices are classified under the EU Medical Device Regulation (MDR) as Class I devices, which means they undergo regulatory scrutiny to ensure compliance with EU safety and performance standards. Since these devices fall under MDR, they must be registered in the EU’s official database, eudamed, to demonstrate their legal conformity and traceability within the European market.

Yes, Eurotape B.V.’s devices are listed in eudamed, the EU’s central registry for medical devices. This matters because eudamed serves as an official public database where healthcare professionals, regulators, and authorities can verify the legal status of devices placed on the EU market. Listing in eudamed ensures transparency and compliance with MDR requirements, allowing stakeholders to confirm that the devices meet EU regulatory standards before use.

Eurotape B.V.’s devices are classified as Class I under the EU MDR. This classification is determined by factors like the device’s intended use, risk level, and interaction with the body. Class I devices are generally considered low-risk, but they still must comply with EU safety and performance requirements, including proper labeling, manufacturing controls, and post-market surveillance. The classification ensures that even low-risk products meet essential regulatory expectations before being marketed in the EU.