Certifications & Compliance

ISO Certified and CE Compliant Manufacturing

Sanitas Plus maintains high production standards and regulatory compliance to ensure the quality and safety of its dental cotton products.

CE Conformity

MDR 2017/745 – Class I Medical Device

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ISO 13485 Certification

Medical Device Quality Management System

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ISO 9001 Certificate

Quality Management System

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ISO 14001 Certification

Environmental Management System

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TS EN 14971

Risk Management in Medical Devices

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Certificates

It is produced under controlled production standards, using premium Turkish cotton.

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REGISTERED IN UTS COMPLIANCE WITH THE EUROPEAN MEDICAL DEVICES REGULATION (EU) 2017/745