Kolmi Feeldry Tie-on Mask, Type IIR, Blue

Standards and labels

• EN ISO 13485

  Medical devices with the EN ISO 13485 rating are tested for the quality management system used in their design, production, and servicing. This ensures the devices are consistently safe, reliable, and meet strict regulatory standards for your peace of mind.

  Reach out to ask about the standard test results

• 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

• EN ISO 9001:2015

  Products with the EN ISO 9001:2015 rating are tested for consistent quality management processes to meet customer and regulatory requirements. This means you can expect reliable products and services, as the company is committed to improving customer satisfaction.

  Test results

  Service Reliability Passed

  This product is backed by a quality management system that ensures you receive consistent and dependable service. It focuses on providing reliable support and a positive customer experience, from initial contact to post-delivery activities.

• 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.

• MD Label

  MD stands for "Medical Device." It refers to any instruments, apparatus, machines, implants, or other similar or related articles that are intended to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability. In Europe, a MD Label is a special label that must be on all Medical Devices that are sold or used in the European Union (EU). The label must include information about the product, such as the name of the manufacturer, the intended use of the product and CE mark. To be able to sell or use a Medical Device in the EU, the device must meet certain standards and requirements set by the European Union and notified body.

• PPE Category 1

  PPE stands for "personal protective equipment." PPE Category 1 refers to equipment that is simple and easy to use, and has a lower level of risk. Examples of PPE Category 1 include gloves, goggles, and simple respirators. In Europe, PPE Category 1 must meet certain safety standards set by the European Union. This means that it must be designed and manufactured to protect the user without causing harm. Companies that make or sell PPE must prove that it meets these standards.