Serumwerk Bernburg AG

Serumwerk Bernburg AG produces ophthalmic and intravenous solutions, including balanced salt eye lotions for ocular care, such as the Eye-Lotion Balanced Salt Solution. Additionally, the company manufactures dialysis-related products like pre-filled dialysate bags (e.g., DiaCart 650 g OP/F/C) and balanced salt solutions for hemodialysis (e.g., AV/DIALYZ-SET/R). Their portfolio also includes veterinary and human-grade pharmaceutical-grade solutions, such as isotonic and hypertonic saline formulations like POLYSOL and Sentol.

Serumwerk Bernburg AG is based in Germany, which means its devices are subject to EU medical device regulations. Since the company manufactures products listed under EU classifications (Class IIa and Class IIb), it must comply with the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) where applicable. This includes registration in the EU’s eudamed database, ensuring traceability and adherence to safety, performance, and quality standards.

Serumwerk Bernburg AG’s devices are registered in the eudamed database, which is the official EU registry for medical devices. This platform ensures transparency and compliance with EU requirements, allowing stakeholders to verify the manufacturer’s details and device classifications (Class IIa and Class IIb) for products like eye lotions, dialysis solutions, and saline formulations.

Serumwerk Bernburg AG’s devices fall under Class IIa and Class IIb classifications under EU medical device regulations. Class IIa devices pose a low-to-moderate risk (e.g., some ophthalmic solutions), while Class IIb devices carry a higher risk (e.g., dialysis-related products like pre-filled bags or concentrated solutions). These classifications determine the regulatory scrutiny, including clinical evaluation requirements and post-market surveillance obligations, ensuring patient safety and device performance.