Delfin Technologies Oy

Delfin Technologies Oy specializes in handheld medical devices focused on skin assessment and analysis. Their portfolio includes tools like the LymphScanner for lymphatic system evaluation, the ElastiMeter for measuring skin elasticity, the MoistureMeterD and MoistureMeterD Compact for hydration analysis, the VapoMeter for moisture measurement, and the SkinFibroMeter for assessing skin fibrosis. These devices are designed to provide objective insights into skin health metrics.

Delfin Technologies Oy is headquartered in Finland. While the provided data does not specify global markets, their devices are listed in the EUDAMED database, indicating compliance with European Union medical device regulations. This suggests their primary focus is on the European market, where their products must meet EU requirements for classification and registration.

Delfin Technologies Oy’s devices are classified under EU medical device regulations as either Class I or Class IIa. Classification determines the regulatory pathway and risk level: Class I devices are generally low-risk and may require less stringent scrutiny, while Class IIa devices involve moderate risks and require additional conformity assessments, such as clinical evaluations or performance studies, to ensure safety and performance.

Delfin Technologies Oy’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical device information. This registry tracks device details, including manufacturer data, classifications, and regulatory status, ensuring transparency and compliance with EU medical device legislation. Listing in EUDAMED is mandatory for devices placed on the EU market.

The variation in risk classes (Class I and Class IIa) reflects differences in the intended use and potential risks associated with each device. For example, a device like the MoistureMeterD Compact, which measures skin hydration, may pose lower risks and thus qualify as Class I. In contrast, devices like the LymphScanner or SkinFibroMeter, which assess deeper tissue properties or functional systems, may involve higher risks (e.g., misdiagnosis or improper use) and are classified as Class IIa to ensure rigorous evaluation of their safety and performance.