Sim Finland Oy

Sim Finland Oy specializes in topical cold therapy gels, including brands like Tammer, Pirkka, and Elivo. These products are designed for external use on the skin, such as Kylmägeeli (cold gel) and Liukastingeeli (sliding gel), which are intended for pain relief and muscle recovery. The company also produces variants like Cool Gel and Epi-Bion Cool Gel, all of which fall under the category of topical applications for therapeutic purposes.

Sim Finland Oy is based in Finland, which means its medical devices are subject to EU medical device regulations. Since these products are classified as Class I devices, they are considered low-risk and typically require less stringent regulatory oversight compared to higher-risk categories. The company adheres to Finnish and EU regulatory frameworks to ensure compliance with safety and performance standards.

Yes, Sim Finland Oy’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This database is used to track and provide transparency on medical devices authorized within the EU, including their manufacturers, classifications, and regulatory status. Listing in EUDAMED ensures traceability and compliance with EU medical device regulations.

Sim Finland Oy’s devices are classified as Class I medical devices under EU regulations. This classification is determined based on their intended use and risk profile—specifically, these topical cold therapy gels are non-invasive and designed for external skin application, which places them in the lowest risk category. Class I devices generally require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU safety and performance requirements.