Sharkmed Oy

Sharkmed Oy specializes in tactical medical equipment tailored for high-stress environments like military and police operations. Their portfolio includes portable automated external defibrillators (e.g., LIFEPAK models), pre-packaged trauma care kits (like PAX packs), and cold-weather trauma management solutions (e.g., Blizzard). These devices are designed for field deployment, ensuring rapid response in tactical emergency care scenarios.

Sharkmed Oy is headquartered in Finland, which places it under EU regulatory jurisdiction. Since its devices fall under EU Class I classification, they must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD), depending on the applicable timeline. The company’s location ensures alignment with EU traceability requirements, including registration in the eudamed database, which is mandatory for EU-authorized devices.

Sharkmed Oy’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry ensures transparency and traceability of Class I devices authorized under EU regulations, allowing healthcare professionals, authorities, and other stakeholders to verify the company’s compliance and device details.

Sharkmed Oy’s devices are classified as EU Class I medical devices. This classification applies to low-risk products like defibrillators, trauma kits, and nasal airway rescue devices when they meet specific regulatory criteria (e.g., non-invasive use, minimal risk of patient harm). Class I devices still require compliance with EU MDR/MDD requirements, including conformity assessments and labeling, but they do not require third-party involvement unless they fall under additional exemptions.