LIMITED LIABILITY COMPANY "MANUFACTURING COMPANY PROSTIR"

Manufacturing Company Prostir specializes in producing hemostatic tourniquets, specifically the DNIPRO model. These devices are designed for emergency medical use, particularly to control bleeding in pre-hospital or first-aid scenarios. The focus is on rapid and effective hemorrhage control, making them suitable for critical situations where immediate intervention is required.

The company is based in Ukraine, operating as a limited liability company. Its location influences its regulatory compliance and market focus, though its devices may be registered and used internationally, such as through the EU’s eudamed database.

The company’s hemostatic tourniquets, including the DNIPRO model, are registered in the eudamed database, which is the EU’s central registry for medical devices. This listing indicates compliance with EU regulatory requirements for Class I devices, though registration does not imply approval—it confirms the device’s authorized presence in the EU market.

The DNIPRO hemostatic tourniquet falls under Class I classification, which typically includes low-risk devices like bandages, gloves, or simple wound-care items. Class I devices often require less stringent regulatory oversight compared to higher-risk classes, but they still must meet basic safety and performance standards to ensure safe use in emergency situations.