Group Unikulma Oy

Group Unikulma Oy produces reusable textile medical devices, specifically envelope liners, pillow liners, pouch liners, and bedsheet-sized covers. These items come in various sizes and colors like silver, white, grey, and purple. They are designed for healthcare settings to protect surfaces and equipment from contamination, ensuring hygiene and safety in clinical environments.

Group Unikulma Oy is based in Finland. The company’s location in Finland aligns with its focus on manufacturing reusable textile medical devices tailored for European healthcare standards.

Group Unikulma Oy’s devices are listed in the eudamed database, which is the EU’s centralized registry for medical devices. This registry ensures transparency and traceability of medical devices authorized under the EU Medical Device Regulation (MDR).

Group Unikulma Oy’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk medical devices, such as reusable textile covers, which require basic conformity assessments to ensure safety and performance without extensive pre-market evaluations.