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The agency determined that the risks posed by the OTC products were well established and premarket notification was not necessary to provide reasonable assurance of the product’s safety and effectiveness. Read More
The new regulations included a new register of medical devices and the Czech Ministry of Health is now responsible for registering devices and postmarket surveillance. Read More
The product is created with regenerated oxidized cellulose and designed to control bleeding and absorb exudate and drainage from superficial wounds. Read More
The company was awarded a grant of $1.4 million last December for clinical validation of the device by the European Fund for Regional Development. Read More