BloodSTOP® is a natural, biocompatible, non-irritating, animal-free material that adheres to a wound, absorbs blood, stops bleeding, and forms a protective layer to create an environment for wound healing. Its water solubility allows it to be rinsed off without disruption to the clotted surface.
Regulatory Approvals
US FDA 510(k) Surface Use Market Clearance
Professional Use
Emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required.
View Professional Use Instructions for surface wounds
Consumer Use
Topical control of bleeding from minor cuts and abrasions of the skin surface
View Consumer Use Instruction Sheet
CE Mark (EU) Surface Use Approval
External, short-term use hemostatic gauze for the control of bleeding from lacerations, cuts, abrasions, and venipuncture.
CE Mark (EU) Internal Use Approval (BloodSTOP® iX only)
Internal use, wholly absorbable, for the control of bleeding during and after surgery.
View CE Class III Internal Use Instruction Sheet
US FDA Internal Use (BloodSTOP® iX only)
Not yet approved.
ISO 13485:2003 Certification
International standard for medical device manufacturing
"It has been scientifically proven that advanced dressings are superior to the traditional gauze and bandages, since the healing time is significantly reduced and the overall quality of care received is superior with these dressings."
"A Look at Today's Wound Care Market"
Minakshi Krishnan, Frost & Sullivan (11/03)
