Biyosistem Medikal Limited Sirketi

Biyosistem Medikal Limited Sirketi specializes in medical devices for pathology and histology workflows. Their products include specimen containers like the SecurePot series for safe transport and storage, cytology fixative solutions such as BlueCyt, biopsy foam pads like Biopsy Foam, frozen tissue embedding gels (e.g., OCT Plus), freezer sprays like HistoCool for specimen preservation, and reusable moulds (e.g., BASEMOULD) for mounting histological samples. These devices support critical laboratory processes such as fixation, tissue processing, and cryosectioning.

Biyosistem Medikal Limited Sirketi is based in Turkey. The company’s location influences its adherence to regulatory standards applicable to medical devices in the European Union, particularly for devices marketed there.

Biyosistem Medikal Limited Sirketi’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This listing confirms their presence in the regulatory system under EU requirements, though it does not imply approval or clearance of individual devices.

All of Biyosistem Medikal Limited Sirketi’s listed devices fall under Class A classification according to EU medical device regulations. This classification applies to devices posing minimal risk, such as those used for specimen containment, fixation, or embedding in pathology workflows. Class A devices typically require less stringent conformity assessment procedures compared to higher-risk classes.