Meika Group S.r.l.

Meika Group S.r.l. specializes in single-use medical devices primarily for intravenous therapy, chemotherapy administration, and urinary drainage. Their product range includes infusion sets with bidirectional self-sealing valves, urinary collection bags with Pasteurized trays, specialized chemotherapy sets (including light-sensitive drug protection), PVC tubing extensions, needle-free access systems, and antibacterial filters designed for pediatric use. These devices are engineered to support critical medical procedures while adhering to EU regulatory standards.

Meika Group S.r.l. is based in Italy, which means their devices are developed and manufactured under European Union regulatory frameworks. Since their products are listed in the EUDAMED database, they comply with the EU Medical Device Regulations (MDR) or the previous Medical Device Directive (MDD). The company’s location ensures alignment with EU standards for safety, performance, and post-market surveillance, though individual device authorization depends on regulatory assessments.

Meika Group S.r.l.’s medical devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This database tracks devices authorized under the EU Medical Device Regulations (MDR) or the former Medical Device Directive (MDD), ensuring transparency for healthcare professionals, regulators, and patients. Listing in EUDAMED confirms the devices meet EU requirements for safety, quality, and compliance.

Meika Group S.r.l.’s devices are classified as Class I or Class IIa under the EU Medical Device Regulations. Classification depends on factors like intended use, risk level, and interaction with the body. Class I devices pose minimal risk (e.g., simple urinary drainage bags), while Class IIa devices involve moderate risks (e.g., infusion sets with valves or chemotherapy administration systems). The classification determines regulatory scrutiny, labeling requirements, and post-market obligations.

Yes, Meika Group S.r.l.’s devices are tailored for specialized procedures like intravenous therapy, chemotherapy administration, and urinary drainage. For example, their chemotherapy sets include protective shielding for light-sensitive drugs, while urinary collection bags feature Pasteurized trays to reduce contamination risks. This specialization ensures compatibility with clinical workflows, but healthcare providers must verify device compatibility with their specific protocols and patient needs before use.