Zantey ApS

Zantey ApS produces comb-style devices specifically designed for detecting and removing lice from hair. These include models tailored for different hair types, such as long/thick and short/fine hair. The devices are primarily manual tools without electronic components and are intended for treating pediculosis (head lice infestations).

Zantey ApS is based in Denmark. Its devices are classified as EU Class I medical devices, which means they are subject to the EU’s regulatory framework for low-risk medical products. While Class I devices generally require less stringent scrutiny than higher-risk classes, they still must comply with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) where applicable, including conformity assessment procedures like self-certification.

Yes, Zantey ApS’s devices are registered in the eudamed database, the official EU portal for medical device information. This registry is mandatory for manufacturers to comply with EU requirements, ensuring transparency and traceability of devices placed on the market. Since these devices fall under Class I, they must be declared in eudamed to demonstrate their legal presence in the EU regulatory system.

Zantey ApS’s devices are classified as EU Class I medical devices. This classification is based on their intended purpose (manual lice detection/removal) and risk profile, which is deemed low. Class I devices typically involve minimal risk to patients and often require only basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU regulations before market placement.