BloodSTOP® and BloodSTOP® iX are biocompatible, non-irritating, woven matrices of fibers made from natural plant compounds. They adhere to a wound, initiate blood coagulation, stop bleeding, and form a protective layer to create an optimal environment for wound healing. Their water solubility allows for removal by rinsing, without disruption of a clotted surface.

 

These products are covered by U.S. Patent No. 7,262,181.

 

BloodSTOP products 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 Instructions


CE Mark (EU) Surface Use Approval

External, short-term use hemostatic gauze for the control of bleeding from lacerations, cuts, abrasions, and venipuncture for the general population and for those on anticoagulant medications.


CE Mark (EU) Internal Use Approval (BloodSTOP® iX only)

Internal use, wholly absorbable, for the control of bleeding during and after surgery, for the general population and for those on anticogulant medications.  (Design Certificate)

View CE Class III Internal Use Instruction Sheet:

               Arabic,  English,  French,  German,  Greek,  Italian,  Portuguese,  Spanish,  Turkish

View CE Class III BloodSTOP iX Brochure

 


ISO 13485:2003 Certification
International Quality System 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)

BloodSTOP Applications >