Frequently Asked Questions

BloodSaver is a new line of hemostatic agents from the team that developed the first Ukrainian hemostatic agent, "Krovospas". The product is manufactured by Taktyspas LLC, which has implemented a quality management system under the ISO 13485 standard and obtained a certificate of conformity for its entire range of hemostatic agents. BloodSaver is based on a formula developed in 2014, but the current product has been adapted to the requirements of modern tactical medicine.

Yes, BloodSaver is legally placed on the market and approved for use in Ukraine. As it is a Class IIb medical device, under clause 17 of the Technical Regulation on Medical Devices (approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 of 2 October 2013) , it is placed on the market through a conformity assessment carried out by an accredited certification body. Having successfully completed this procedure at the accredited body UCMSP , BloodSaver hemostatic agents received the full package of authorization documents: a Certificate of Conformity (No. UA.TR.098.0571-26), a Quality Management System certificate compliant with DSTU ISO 13485:2018, and a Declaration of Conformity for medical devices.

Customers sometimes ask why the device is not listed in the electronic "Register of persons responsible for placing medical devices, active implantable medical devices, and in vitro diagnostic medical devices on the market". We emphasize that the current legislation of Ukraine neither provides for nor requires duplicating information about Class IIb devices in that register.

Under Order of the Ministry of Health of Ukraine No. 122 of 10 February 2017 and clause 31 of the Technical Regulation on Medical Devices (approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 of 2 October 2013) , this Register contains information exclusively about Class I medical devices, custom-made medical devices, and medical-device systems and procedure packs.

For Class IIb medical devices (such as BloodSaver hemostatic agents), the Certificate of Conformity and the Declaration of Conformity are the definitive, exhaustive, and self-sufficient confirmation of their legality on the Ukrainian market.

The address of the production site is not disclosed for security reasons: the product is supplied to the Defense Forces, and revealing the production coordinates is unacceptable in wartime. At the same time, the production site has been inspected by the designated body UCMSP during an audit (including validation of clean zones) and is known to the state regulatory authorities.

All current documents (certificates and the declaration) are published in the "Certificates" section of the website. You can verify the validity of the certificates yourself with the accredited body UCMSP (by calling their hotline or sending a request by mail or email). On request, we provide the full document package to procurement buyers, foundations, and units through a secure channel.

BloodSaver is manufactured at a medical facility with an implemented ISO 13485:2018 quality management system. The production site has passed an audit by the designated body UCMSP with validation of clean production zones, as confirmed by the certificate. All products are released sterile, in vacuum packaging, in compliance with the requirements of the Technical Regulation on Medical Devices.

The product is impregnated with a special kaolin-based hemostatic composition (it contains no substances of animal origin, such as chitosan, that may cause allergic reactions). It does not heat up on contact with blood, does not cause burns or tissue necrosis, does not enter the bloodstream, does not provoke thrombosis, and is easily removed from the wound. This has been confirmed within the conformity assessment (biocompatibility per ISO 10993).

The BloodSaver medical device originates from a Ukrainian development of 2014 and has been refined for years based on combat-use experience. As a registered medical device under the BloodSaver brand, the product has been manufactured since early 2026 — a valid certificate of conformity was issued and a declaration of conformity was drawn up as of 30 January 2026. The product is continuously improved based on feedback from military medics.

You can order products on the website bloodsaver.net or through a manager via any convenient messenger. Sales are conducted officially through Taktyspas LLC with proper documentation; delivery is by "Nova Poshta" across Ukraine. A 15% discount applies to members of the Defense Forces of Ukraine.