TUGI Model 2 is designed to facilitate and enhance the administration of injectable drugs Clexane and Fraxiparine in the treatment and prevention of thrombosis. It is designed to help patients comply with their prescribed treatment. TUGI helps patients overcome fear of pain or self-injury by providing the right angle of injection and restricting unwanted and painful needle movement in the body. TUGI makes it easier to handle the syringe for people who have tremors in their hands, impaired fine motor skills of their fingers or other health restrictions.
TUGIs are approved for adult users only. TUGIs are not intended for unlisted medications (e.g., diabetes medications). TUGIs’ innovation is protected by a number of registered industrial designs, patents, and trademarks in the EU, USA, Canada, Switzerland, Japan, Republic of Korea, India, Norway, Russia, and other countries. The principle, design, and names of these products are protected. In the EU, TUGI is classified as a risk class I, non-sterile, non-measuring medical device (according to Annex VII of European Regulation 2017/745). The declaration of conformity guarantees compliance with EN ISO 14971:2012, EN ISO 10993-5:2009, EN ISO 10993-10:2013 from the manufacturer.
TUGIs are made of high-quality and certified medical grade silicone ELASTOSIL from the renowned German company Wacker Chemie AG, which complies with DIN EN 1400:2014-07 and DIN EN 14350-2:2004-11. An accredited laboratory has confirmed that TUGI applicators are made of material that is non-cytotoxic (according to ISO 10993-5) and does not cause skin irritation (according to ISO 10993-10). TUGI is manufactured exclusively in the EU, in an ISO 14001:2015, ISO 9001:2015, and IATF 16949:2016 certified manufacturing facility.
Follow the instructions below to use the applicator with Clexane.
Follow the instructions below to use the applicator with Fraxiparine.
TUGI is an over-the-counter medical device intended for repeated use. TUGI is intended for adult users but not for children. The applicator is only suitable for compatible pre-filled syringes (not part of the package). TUGI can be purchased online (and in select pharmacies in the near future).