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INTERNATIONAL QUALITY & CONFORMITY

Global Quality Standards.

World-class certified production conforming to CE 0426 MDR, FDA Registered, ISO 9001:2015, and ISO 13485:2016.

INTERNATIONAL CERTIFICATE OF COMPLIANCE

CE Certificate

European conformity certificate.

CE Certificate
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INTERNATIONAL CERTIFICATE OF COMPLIANCE

FDA Certificate

US Food and Drug Administration approval certificate.

FDA Certificate
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INTERNATIONAL CERTIFICATE OF COMPLIANCE

ISO 9001 Certificate

Quality Management System standard.

ISO 9001 Certificate
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INTERNATIONAL CERTIFICATE OF COMPLIANCE

ISO 13485 Certificate

Medical Device Quality Management System.

ISO 13485 Certificate
✓ Audited & Current
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