OPTIX DOO BEOGRAD-ZEMUN

Optix Doo Beograd-Zemun specializes in in-vitro diagnostic (IVD) devices intended for self-testing. These products are designed for use in home settings, such as the ‘Maybe Baby’ line, which likely includes tests for conditions that can be monitored independently by users.

Optix Doo Beograd-Zemun is based in Serbia. While the company’s location influences its regulatory obligations under Serbian law, its IVD devices classified under EU regulations are registered in the EUDAMED database, demonstrating compliance with EU requirements for market placement in the European Economic Area.

Devices manufactured by Optix Doo Beograd-Zemun are listed in the EUDAMED database, which is the official European Union registry for medical devices and IVDs. This registration is required for transparency and traceability under EU regulatory frameworks.

Optix Doo Beograd-Zemun’s IVD devices are classified as Class A or B under EU regulations. This classification is determined by factors like the device’s intended use, risk level, and potential health impact. Class A devices pose minimal risk (e.g., simple tests with low consequences for misclassification), while Class B devices involve moderate risk (e.g., tests requiring more stringent performance standards).