EC DECLARATION OF CONFORMITY
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EC DECLARATION OF CONFORMITY
Product catalog summary
Manufacturer Information: Öncü Dental Tıbbi Malzeme Sanayi ve Dış Ticaret Anonim Şirketi, headquartered in Istanbul, Turkey, with a production site in Esenyurt, Istanbul. Contact details include phone numbers and a website.
Product Details: The document refers to a product listed in Annex-1, specifically a Dental Matrix Band with GMDN Code 38786. It is a Class I medical device under Rule 5, designed for forming a mold around a tooth for restorative materials.
Conformity Assessment: The product complies with the EU 2017/745 Medical Device Regulations and relevant national requirements. The conformity assessment route includes Annex IV Declaration Conformity (Annex II & III).
Quality Management System: The applied system is EN ISO 13485:2016, with additional harmonized standards such as EN 1041+A1:2013, EN 62366-1/AC:2015, NBOG 2010-1, EN ISO 14971:2019, and EN ISO 15223-1:2016.
Declaration: The manufacturer declares that the listed medical devices meet the necessary regulations. The CE marking start date is 30.08.2020, and the declaration is valid until 10.11.2024.
Authorized Signatories: The document is signed by V. Duygu Memiş, Quality and Regulatory Affairs Manager, and Erkan Uçar, CEO.
Annex-1 Product List: Includes a product named Transparent Matrix with a specific barcode number.
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Catalog excerpts
EC DECLARATION OF CONFORMITY AT UYGUNLUK BEYANI Document Code | Dokuman Kodu Release Date | Yayın tarihi Revision Date | Revizyon tarihi DECLARATION AS THE MANUFACTURER, WE DECLARE THAT THE MEDICAL DEVICES WHICH ARE LISTED IN ANNEX-1, MEET THE REQUIREMENTS OF THE 2017/745 MEDICAL DEVICE REGULATIONS AND THE RELEVANT NATIONAL REQUIREMENTS BEYAN ÜRETİCİ OLARAK EK-1'DE BELİRTİLEN TIBBİ CİHAZLARIN 2017/745 TIBBİ CİHAZ YÖNETMELİĞİ VE İLGİLİ ULUSAL GEREKLİLİKLERİ KARŞILAŞTIĞINI BEYAN EDERİZ. CE MARKING START DATE CE MARKALAMA BAŞLANGIÇ TARİHİ PLACE, DATE | YER, TARİH ISTANBUL, TURKEY İSTANBUL, TÜRKİYE...
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