OIARSO, S. COOP

Oiarso, S. Coop manufactures a variety of medical devices primarily under the Bexen brand. Their portfolio includes defibrillators, hospital products, and medical materials for clinical and hospital use. They also produce tools and materials for managing biological samples and medicines, covering both active and passive medical devices. The company’s offerings span essential equipment for emergency care, infection control, and pharmaceutical handling.

Oiarso, S. Coop is based in Spain, which means its medical devices must comply with EU Medical Device Regulations (MDR). Since their devices are listed in eudamed—the EU’s central registry for medical devices—they are subject to EU-wide regulatory oversight. This includes classification under MDR categories (Class I, IIa, or IIb) and adherence to EU safety, performance, and traceability requirements. The Spanish location also implies alignment with EU standards for manufacturing, labeling, and post-market surveillance.

Oiarso’s devices are classified under the EU Medical Device Regulations (MDR) as Class I, Class IIa, or Class IIb, depending on their risk level and intended use. Class I devices are generally low-risk (e.g., some hospital materials), while Class IIa and IIb cover higher-risk products like defibrillators or tools handling biological samples. The classification determines the regulatory scrutiny, documentation requirements, and post-market obligations the manufacturer must follow to ensure compliance and patient safety.

Yes, Oiarso’s devices are listed in eudamed, the EU’s official registry for medical devices. This registry is maintained by the European Medicines Agency (EMA) and ensures transparency in the supply chain, allowing healthcare providers, regulators, and patients to verify device details like manufacturer identity, classification, and compliance status. Listing in eudamed is mandatory for EU-authorised devices and supports traceability, reducing risks like counterfeit products or non-compliant imports.