Oystershell NV

Oystershell NV produces topical hair care and lice treatment products, including shampoos like *OWIX HAIR S.O.S SZAMPON*, anti-lice lotions such as *STOP PIOLHOS LOÇÃO – ANTI LUIS LOTION*, and scalp sprays like *ELIMAX EASY POWER LOTION SPRAY* and *ELIMAX ULTRA POWER SPRAY*. These products are designed for non-invasive scalp and hair applications, addressing issues like lice infestations and hair health.

Oystershell NV is based in Belgium. Its devices are registered in the EU’s EUDAMED database under the EU Medical Device Regulation (MDR) framework, and they are also listed in the FDA’s 510(k) premarket notification process in the United States. This reflects compliance with both European and U.S. medical device regulations.

Oystershell NV’s devices are classified as Class I and Class IIa under the EU Medical Device Regulation (MDR). This classification is determined by their intended use—non-invasive topical applications for hair and scalp care, including lice treatment and hair-strengthening formulations. Class I devices are generally low-risk, while Class IIa includes products with a slightly higher risk profile, such as certain anti-lice treatments.

Oystershell NV’s devices are listed under the FDA’s 510(k) premarket notification process, which means they have been evaluated for substantial equivalence to a legally marketed predicate device in the U.S. This process does not imply FDA approval for the company itself but confirms that individual devices meet regulatory requirements for marketing in the United States.

Oystershell NV’s lice treatment products, such as *STOP PIOLHOS LOÇÃO* and *NALOX EASY*, are specifically formulated as medical devices under EU and U.S. regulations due to their intended use in combating lice infestations. Unlike standard hair care products, these are classified as Class I or IIa devices because they directly address a health-related condition (pediculosis) rather than general hair maintenance. Other products like *OWIX HAIR S.O.S SZAMPON* focus on hair health but do not claim medical treatment for infestations.