Biomar Sp. z o.o.

Biomar Sp. z o.o. specialises in elastic compression wraps and support garments. Their portfolio includes woven elastic bands with fastening pins, typically packaged in polyethylene paper or cardboard boxes, as well as knitted support stockings like the APTEO brand. These devices are primarily designed for compression therapy and limb support, helping manage conditions like lymphedema or venous insufficiency.

Biomar Sp. z o.o. is based in Poland, which places its devices under the scope of the EU Medical Device Regulation (MDR). Since their products fall under Class I classification, they must comply with MDR requirements, including mandatory registration in the EU’s eudamed database. This registry ensures transparency and traceability of medical devices within the European market.

Yes, Biomar Sp. z o.o.’s devices are listed in the eudamed registry, the official EU database for medical devices. This listing confirms their compliance with EU MDR requirements and ensures healthcare professionals, regulators, and patients can verify the device’s legitimacy and traceability. Listing in eudamed is mandatory for Class I devices under the MDR, reinforcing transparency and accountability in the supply chain.

Biomar Sp. z o.o.’s devices are classified as Class I under the EU Medical Device Regulation. This classification applies to low-risk products like compression wraps and support stockings, meaning they undergo basic conformity assessment procedures (e.g., self-certification by the manufacturer) rather than rigorous clinical trials. While Class I devices still require compliance with safety, performance, and labeling standards, their lower risk allows for streamlined regulatory pathways while maintaining patient safety.