Holder of Certificate: farcomake for advancedMEDICAL INDUSTRY S.A.E New Borg Al-Arab Industrial City Area 4, Block 2 Part 7,16 Alexandria EGYPT Certification Mark: Applied Standard(s): FARCOMAKE FOR ADVANCED MEDICAL INDUSTRY S.A.E New Borg Al-Arab Industrial City, Area 4, Block 2 Part 7,16, Alexandria, EGYPT Manufacture or production, servicing, installation and distribution of a medical device (Manufacturer of sterile Dialysis line, Dialysis needle, endotracheal tube, infusion set, peripheral intravenous catheter, suction tube, urological catheter non self-retaining, NASO-GASTRIC-INTESTINAL TUBES, Blood Transfusion set, fluid collection bags, stopcok and DEVICES FOR COLLECTION OF FLUIDS FROM SITES OF OPERATION). (EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021) Medical devices - Quality management systems -Requirements for regulatory purposes The Certification Body of TUV SUD Product Service GmbH certifies that the company mentioned above has established and is maintaining a quality management system (excluding subclause 7.3), which meets the requirements of the listed standard(s). All applicable requirements of the Testing, Certification, Validation and Verification Regulations TUV SUD Group have to be complied with. For details and certificate validity see: www.tuvsud.com/ps-cert?Q=cert:Q6 119354 Report No.: Valid from: Valid until: Date, [#ISU_DT#] Christoph Dicks Head of Certification/Notified Body TUV SUD Product Service GmbH • Certification Body • Ridlerstrafte 65 • 80339 Munich • Germany
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