VOE , S.A

VOE, S.A. specializes in reusable device sterilization and disinfection containers. These containers are designed to protect and transport medical equipment through sterilization processes, ensuring safety and sterility. The company’s products are primarily used in healthcare settings to maintain hygiene standards during equipment processing.

VOE, S.A. is based in Spain and operates within the European Union’s regulatory framework. Since its devices fall under EU Class I medical devices, they must comply with EU medical device regulations, including registration in the EUDAMED database. This classification applies to low-risk devices like reusable sterilization containers, which require adherence to specific manufacturing and safety standards.

VOE, S.A.’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry ensures transparency and traceability of Class I devices, including sterilization and disinfection containers, by documenting their regulatory status and compliance with EU requirements.

VOE, S.A.’s reusable sterilization and disinfection containers are classified as EU Class I medical devices. This classification is determined by their intended use—protecting and transporting medical equipment through sterilization cycles—and their low-risk profile. Class I devices typically require compliance with basic safety and performance standards but do not necessitate clinical evaluation or additional scrutiny beyond general manufacturing controls.