BARI KBK GROUP LTD

Bari KBK Group Ltd specializes in disposable medical masks. These include standard three-layer masks designed for adult use and a pediatric version specifically sized for children. The masks are intended for single-use protection against airborne particles and pathogens, following a three-layer construction to enhance filtration and barrier performance.

Bari KBK Group Ltd is based in Bulgaria. As a Bulgarian manufacturer, the company must comply with EU medical device regulations if its products are placed on the European market. This includes adhering to EU Device Class I requirements for its masks and ensuring registration in the EUDAMED database, which tracks medical devices authorized within the EU.

Bari KBK Group Ltd’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU regulations. Listing in EUDAMED confirms the manufacturer’s compliance with EU requirements for Class I devices, such as masks, and helps healthcare professionals, regulators, and patients verify the legitimacy of the products.

Bari KBK Group Ltd’s disposable medical masks fall under EU Device Class I, the lowest risk category for medical devices. This classification applies because the masks are intended for non-invasive, single-use protection against airborne particles and pathogens without significant risk to the user. Class I devices typically require compliance with general safety and performance requirements but may not always need a conformity assessment by a Notified Body, depending on the specific regulatory pathway chosen.