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

BloodSTOP® iX Trauma Matrix is indicated for external temporary control of minor to moderate bleeding of traumatic 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 13485:2016 Certification
International Quality System Standard for Medical Device Manufacturing