Uluslararası kalitede
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Yümnü Balçık, one of the founding members of Yüce Medical Devices, stepped into the health sector in 1981; He gained experience in the branches of surgery, gynecology and IVF laboratories in import and marketing companies. In 1994, he came together with his brother Cengiz Balçık and established Yüce Medical Device Import Export Representation Industry and Trade Limited Company.
Yüce Medical Supplies has operated only in the field of import and sales until 1996 and established its own factory in 1997 by carrying its experiences in this field to the production area. Yüce Medical Supplies, which has been producing gauze and cotton since 1997, has been producing medical plastic materials and surgical sutures under the name of Edinmed and SSM companies.
Yümnü and Cengiz Balçık brothers have invested in Yüce Medical Supplies company from a large group. Aiming to provide added value and employment by investing in our country, the two partners established a gauze production folding and packaging facility in Şanlıurfa Organized Industrial Zone at the beginning of 2007, and a production facility for SSM and Edinmed companies in Çerkezköy Organized Industrial Zone. The factories established have been complied with GMP and EU norms and have been accredited by the EU's 2764 organization. Our company has successfully passed the audits by the certification body accredited with the EU No 2764 by fulfilling the requirements of the EU legislation and directives coming with the law numbered 4703. EN-14079 compliance has obtained ISO 9001 Quality Management System, EN ISO 13485 Quality Management System for Medical Devices and CE 2764 certificates and successfully passes routine controls after receiving the certificates. Our company, which put cotton cleaning and hydrophilic cotton units into operation at the end of 2008, has produced enough cotton yarn to meet its use for its own production, and has also been fully integrated by commissioning hydrophilic cotton production lines. Our company, which has made brand agreements with some famous companies in the world, has also added products such as gauze tampons, cotton rolls, cotton swabs, sterilization rolls, dental cotton, breathing circuits, oxygen masks to its product range.

Sertifika ve Standartlar

703 nolu kanunla gelen AB mevzuat ve direktiflerinin gereklerini yerine getirerek AB’nin 2195 no ile akredite edilmiş belgelendirme kuruluşu tarafından denetimlerden başarıyla geçmiştir.

2007 yılından itibaren hızlı bir revizyon geçiren YÜ-CE Tıbbi, 4703 nolu kanuna gelen AB mevzuat ve direktiflerinin gereklerini yerine getirerek AB’nin 2195 no ile akderite, 14079 Uygunluk, ISO 9001-2000 Kalite Yönetim Sistemi, EN ISO 13485:2003 Tıbbi Cihazlar için Kalite Yönetim Sistemi ve CE 2195 belgelerini almıştır ve belgeleri aldıktan sonra yapılan rutin kontrollerden de başarı ile geçmiştir ve halen başarılı şekilde çalışmalarına devam etmektedir.

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