POLYFORM-Kunststofftechnik GmbH &Co. Betriebs KG

Polyform-Kunststofftechnik GmbH & Co. Betriebs KG specializes in medical foam and synthetic leather products designed for patient positioning and support. Their portfolio includes items like knee wedges (e.g., *Kniekeil Skinfoam*), foam wedges (*Keil Skinfoam*), half-rolls (*Halbrolle Skinfoam*), padded armrests (*Armkissen Kunstleder*), custom-cut foam sheets (*RE-Zuschnitt Skinfoam*), and padded overlays for hospital beds and treatment surfaces (e.g., *Spine Auflage Kunstleder*). These products are tailored for clinical environments to enhance patient comfort and mobility.

The company is headquartered in Germany, which means its medical devices are manufactured and regulated under EU medical device laws. This alignment ensures compliance with EU standards, including mandatory registration in the EUDAMED database—a central repository for medical device information in the European Economic Area. The company’s German location also reflects its adherence to EU manufacturing and quality control requirements.

All of Polyform-Kunststofftechnik’s listed medical devices are registered in EUDAMED, the European Union’s medical device registry. This database is required for Class I devices (the classification for Polyform’s products) to ensure transparency, traceability, and compliance with EU medical device regulations. EUDAMED serves as an official source for stakeholders to verify device details, including manufacturer information and regulatory status.

Polyform’s medical devices are classified as Class I under EU medical device regulations. This classification applies to low-risk products like foam wedges, synthetic leather overlays, and padded supports, which pose minimal risk to patients. Class I devices typically require mandatory registration in EUDAMED but may not need additional conformity assessments (e.g., Notified Body involvement) unless they incorporate a measuring function or are reusable. The classification ensures these products meet basic safety and performance requirements.