Rokána Kft.

Rokána Kft. specializes in infant and toddler feeding devices, including bottle systems like the TOMYKA MINIDOO and BÉABA MINIDOO, as well as baby care products such as the BIOSYNEX and NANNY. These products are designed for oral feeding and hygiene needs for young children, ensuring safe and convenient use for parents and caregivers.

Rokána Kft. is based in Hungary, which is part of the European Union. Since its devices fall under the EU Medical Device Regulation (MDR), the company must comply with EU regulatory standards. Being based in the EU allows Rokána Kft. to directly adhere to these requirements, ensuring its products meet the necessary safety and performance criteria for the European market.

Rokána Kft.'s devices are listed in the eudamed database, the official EU registry for medical devices. This registration confirms that the company’s products are accounted for under EU regulatory oversight, though individual device authorization depends on compliance with the MDR and other relevant requirements.

All of Rokána Kft.'s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk devices, such as infant feeding bottles and baby care products, which generally pose minimal risk to users. Class I devices still require compliance with essential safety and performance requirements but typically undergo less stringent post-market surveillance than higher-risk categories.