KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi.

KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi. specialises in portable and stationary oxygen therapy devices. Their product range includes oxygen concentrators like the Hikoneb Oxybreath Mini 3, Oxybreath Mini 5, and Oxybreath 10L, as well as medical air compressors such as the Hikoneb Aerocare II. They also produce respiratory support tools, including the Hikoneb A103 and HIKONEB 906 S/LCD, and aspirators like the Ecoaspir Plus and HIKONEB 908 DC. These devices are designed to support respiratory care and oxygen delivery.

The company is headquartered in Turkey. This location influences its adherence to Turkish regulatory standards while also ensuring compliance with international medical device regulations, particularly for markets like the EU where its devices may be distributed.

The devices produced by KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi. are listed in the eudamed database, which is the EU’s centralised registry for medical devices. This registry ensures transparency and traceability of devices authorised under EU medical device regulations.

The company’s devices fall under Class IIa and Class IIb classifications in the EU’s medical device regulatory framework. Class IIa devices pose a low to moderate risk, while Class IIb devices carry a moderate to high risk, requiring additional scrutiny and compliance measures to ensure safety and performance before authorisation.

The classification determines the regulatory requirements a device must meet before it can be authorised for use. Class IIa and IIb devices undergo stricter evaluation processes, including clinical data assessment and conformity assessments, to ensure they meet safety, performance, and quality standards. This classification helps users and healthcare providers trust that the devices have been thoroughly assessed for their intended medical purpose.