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.

BloodSTOP iX Trauma Matrix is intended for use as a topical dressing for local management of bleeding wounds such as cuts, lacerations and abrasions. It may also be used for external temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries.

Consumer Use

Control of surface bleeding from minor cuts and abrasions of the skin surface

CE Mark (EU) Absorbable Implant Use Approval (BloodSTOP^® iX only)

Absorbable, implantable use for the control of bleeding during and after surgery, for the general population and for those on anticoagulant medications.

ISO 13485:2016 Certification
International Quality System Standard for Medical Device Manufacturing