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(Conformité Européenne) is a certification mark that indicates conformity with health, safety, and environmental protection standards for our medical products sold within the European Economic Area (EEA). The CE marking is the manufacturer's declaration that their medical products meet the requirements of the applicable EU directive: 93/42/EEC
The United Kingdom belongs to the European Economic Area (EEA).
This is clear information for the United Kingdom doctors, that our products are safe to use with their patients. We care for each other ☔
The UKCA (UK Conformity Assessed) marking is a new UK product marking that is used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required the CE marking.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
The main priority is to ensure the proper quality, efficacy, and safety of medicinal products, medical devices, and biocidal products out of concern for the society’s wellbeing in Poland. The Office obey the national and international law and the directives and guidelines of the European Commission.