Hopen SafeFeet PP Shoecovers with Plastic Coated Sole, Size XXL, White

Standards and labels

• ISO 13485:2016

  Medical devices with the ISO 13485:2016 rating are tested for a quality management system that ensures consistent safety, quality, and regulatory compliance throughout their lifecycle. This provides assurance that the product is reliably produced to high international standards for patient use.

  Test results

  Medical Management Passed

  This product was made under a quality management system that ensures consistent design, production, and distribution. This focuses on the safety, performance, and regulatory compliance of medical devices throughout their entire lifecycle, from design to disposal.

• EN ISO 11737-1:2018/A1:2021

  Healthcare products and medical devices with the EN ISO 11737-1:2018/A1:2021 rating are tested for the amount of live microorganisms on them. This ensures these products are microbiologically safe, confirming effective sterilization and reducing infection risks for users.

  Reach out to ask about the standard test results

• CE Marking

  CE Marking is a label that shows a product meets certain safety and environmental standards set by the European Union. To get the CE Marking, a company must test and certify their product meets these standards. CE Marking is required for many products sold in the EU, including electronics, machinery, toys and medical devices. It helps ensure that products are safe for consumers and the environment, and allows for easy trade within the EU.