ZANTEY HEAD LICE COMBS
Production certified according to ISO 13485
All Zantey head lice combs are manufactured under a certified ISO 13485 Quality Management System. This international standard ensures the design, production, and packaging of medical devices consistently meet regulatory and customer requirements.
Our Quality Management (QM) system is fully compliant with DIN EN ISO 13485 and has been adapted to meet the requirements of the European Regulation on Medical Devices (EU) 2017/745.
We maintain a strong commitment to continuous quality improvement, with management providing the necessary resources, training, and support to uphold these high standards.
Ongoing Quality Assurance
We implement and maintain all required procedures, documentation, and internal processes in strict accordance with ISO 13485 and applicable legal regulations. These systems are regularly reviewed through management reviews to ensure continual improvement and annual internal and external audits.
These efforts ensure our quality system remains effective, current, and in line with evolving regulatory requirements.
View our certification here
Medical Device Classification & CE Marking
Did you know head lice combs are classified as medical devices class I in most parts of the world?
Head lice combs are classified as medical devices class I by health authorities in most parts of the world. This classification means they are intended for diagnosis, prevention, and treatment of head lice, meeting strict regulatory requirements *.
Medical devices must also carry CE marking. Zantey produces CE marked head lice combs, ensuring they meet the required standards for safety, health, and environmental protection in accordance with medical device regulations.
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* According to the European Medical Device Coordination Group (MDCG) definition:
“Medical device - means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: ‒ diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.”
(Source: MDCG 2019-15 – Guidance Notes for Manufacturers of Class I Medical Devices, December 2019)
