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About us
Our Dnipro Tourniquet Generation 2 is recognized not only in the Ukrainian market, but also in the European market, the UK market, and Australia.
To confirm the company's ability to systematically provide medical devices that equally satisfy customer requirements and regulatory requirements applicable to medical devices, since 2022 we have implemented and maintained a quality management system in accordance with the requirements of ISO 13485 for medical devices and ISO 9001 for quality management systems. We have the relevant certificates issued by the international certification body UNISERT, which certify that the management system in accordance with the standards is recognized and implemented.
We have the entire package of documents on compliance with the requirements of the Technical Regulations on Medical Devices approved by the Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013. No. 753, in particular, a technical file, a declaration of conformity, preclinical evaluation, risk assessment, clinical evaluation report, a certificate of conformity for the Tourniquet, which certifies compliance with the requirements of TU 32.5-34228792-001:2022 Tourniquet “Dnipro” with amendments No. 1,2, issued by the certification body, namely SE “Ternopilstandardmetrology”.
In the “Register of persons responsible for putting medical devices into circulation”, the “Dnipro” hemostatic tourniquet, generation 2, is registered under the number 11112.
We have an authorized representative in the European Community. Certificate of CE registration.
Declaration of conformity and technical file that meet the requirements of REGULATION (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices.
Both the manufacturer and the tourniquet are registered in the EUDAMED information system. We have a unique unified registration number of an economic entity in the EUDAMED information system - SRN: UA-MF-000039898.
The EUDAMED system was developed by the European Commission to implement EU Regulation 2017/745 on medical devices, to improve transparency and coordination of information on medical devices in the European Union market.
It should be noted that the Dnipro Hemostatic Tourniquet Generation 2 has been assigned the NATO Stock Number (code) 6515-61-017-6778, (NATO Stock Number, abbreviated NSN). This identifies it as a standardized item of clothing for the Armed Forces of Ukraine and other military formations.
The Company, as a manufacturer, is also assigned the NCAGE code (NATO Commercial and Government Entity) in the NATO codification system.
The NATO nomenclature number is recognized by all NATO countries, including the US Department of Defense.
We are proud that our hemostatic tourniquets pass all the necessary tests and trials to obtain certificates and permits. Most importantly, our products help to save lives at the frontline. We know how important safety is to our customers, so we adhere to the highest standards of quality and safety.