Certificates
Our Quality Certificates
Certificates of our quality management system, the declaration of conformity for our surgical mask and our UTS registration.
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ISO 9001:2015
ISO 9001:2015 Quality Management System
Onaylayan Kurum: International Accredited Certification Body
Compliance of manufacturing of medical surgical masks, supply, sales, and distribution of medical materials.
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ISO 13485:2016
ISO 13485:2016 Medical Devices Quality Management
Onaylayan Kurum: International Accredited Certification Body
Global health regulatory compliance standard in manufacturing medical devices and protective equipment.
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EN 14683+AC:2019 / CE
EN 14683+AC:2019 & CE Compliance
Onaylayan Kurum: Accredited Testing & Assessment Body
Full compliance with bacterial filtration efficiency (BFE ≥ 98%), breathability and splash resistance.
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ÜTS / UTS
Ministry of Health Product Tracking System (UTS) Registration
Onaylayan Kurum: Turkish Medicines and Medical Devices Agency (TITCK)
Atlantis Medical and all manufactured BeyMask surgical masks are officially registered in UTS.
Request a Wholesale or Custom Medical Supply Quotation
Quick quotations and sample dispatch in accordance with technical specifications for healthcare institutions.