Certifications

Group 104

ISO 13485 Certified Production

Production at Zantey is ISO 13485 certified.

The Quality Management (QM) system is designed to ensure and maintain our high quality. The QM system complies with the applicable standard DIN EN ISO 13485, and is adapted to the requirements of the European Regulation on Medical Devices (EU) 2017/745.

The company management is committed to providing the necessary resources and training for employees.

The company establishes, implements and maintains each requirement, procedure, activity or regulation to be documented in accordance with ISO 13485 or applicable legal requirements, including (EU) 2017/745.

Through established and implemented procedures that all employees work by, the company ensures that the QM system remains up-to-date and effective. This is done through regular reviews of procedures by management, as well as annual internal and external audits.

See our certification here

CE Marking

Zantey produces CE marked head lice combs, which means that these products meet EU requirements for safety, health and environmental protection in the field of medical devices.

This CE marking is based on an assessment of the product, materials and our production devices.

Documentation

In accordance with Danish legislation on medical devices, Zantey may only make studies and articles available to persons who purchase, sell or use the product commercially. Therefore, these are not freely available on our website.

If you are a business person who would like further information and documentation on our head lice combs, please contact us at info@zantey.com or via the link below.

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