Safety and Quality

Certification
CE marking

(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 ☔

UKCA marking

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.

Regulatory Authority
Medicines and Healthcare products Regulatory Agency

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.

 

 

European Medicines Agency

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 Office for Registration Medicinal Products, Medical Devices and Biocidal Products

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.

 

 

 

Quality - products in action
SLH - uterine morcellation in the sac

SLH - laparoscopic removal of the uterus, morcellation of the uterus in the sac