About Us
KATON SK s.r.o. is a distributor of these unique medical safety products for the healthcare industry. The SecureGard syringe was designed to save money by reducing medication waste (low dead space) and help reduce needlestick injuries to healthcare workers worldwide through a fully retractable needle.
Manufacturing & Product Support
Our products are manufactured in accordance with the appropriate standards and where applicable are CE marked in accordance with Medical Devices Directive 93/42/EEC and also complies with the 120. Article of Medical Device Regulation 2017/745 EU.
These products have been issued certificates:
EN ISO 13485:2016
EC CERTIFICATE – NE/1024/2021.
Registration within the Slovak Republic, ŠUKL č: P 69145.
Products manufactured by SafeGard are subject to Risk Analysis procedure as described in the standard EN 14971:2019. The aim of the risk analysis is to investigate the safety of a medical device by identifying the hazards and estimating the risks associated with the device.
Accreditations
Needlestick initiative
SafeGard Medical Products Inc. are proud to be closely involved in the Anti-Needlestick initiative.
For further information please visit the websites below.
ABHI
ABHI supports the HealthTech community to provide products and services that help people live healthier lives. As the voice of the industry, they show the value of health technology and overcome barriers to people benefitting from it now and in the future. Members include leading multinationals through to small and medium sized enterprises.
ISIPS
The International Sharps Injury Prevention Society (ISIPS) is an international group of medical device and pharmaceutical manufacturers, health organizations, healthcare professionals, medical waste disposal experts and others that are joining forces to provide education, information, and product knowledge that will help reduce the number of sharps injuries that occur each year.
SafeGard
Location
KATON SK s.r.o.
Račianská 88/B
831 02 Bratislava
Slovakia