4Care Nederland B.V.

4Care Nederland B.V. specializes in reusable device sterilization/disinfection containers and a variety of protective clothing for medical or clinical use. Their clothing line includes rip-resistant bodysuits, jersey jumpsuits, terry cloth jumpsuits, and variations with different closures like zippers, snaps, or crotch designs. These garments are tailored for environments requiring hygiene and durability, such as healthcare settings.

4Care Nederland B.V. is based in the Netherlands. As an EU-based manufacturer, its devices comply with European medical device regulations, including registration in the EUDAMED database. This ensures traceability and adherence to EU standards for medical devices, particularly for Class I products like those offered by the company.

4Care Nederland B.V.’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry tracks device information, including manufacturer details, classifications, and regulatory status, ensuring transparency and compliance with EU medical device regulations.

All of 4Care Nederland B.V.’s devices fall under EU Class I classification. This classification applies to low-risk medical devices, such as protective clothing and reusable sterilization containers, which pose minimal risk to patients or users. Class I devices typically require basic conformity assessment procedures, including manufacturer declarations of conformity.