COLTENE Supply Chain Policy and Due Diligence
Code of Conduct for the suppliers of COLTENE Holding AG
General Terms and Conditions of Sale and Delivery
As a globally renowned manufacturer of dental medical devices, COLTENE is one of the first dental companies to fully comply with the requirements of the MDR (EC 745/2017) in Europe and was able to achieve a certificate for this at the beginning of 2020.
The worldwide acting quality management team also ensures that all products are always kept up to date with regards to the requirements for medical products.
This means that the COLTENE Group’s customers can be confident that they are working exclusively with products that meet both the highest quality criteria and all regulatory requirements.
Coltène/Whaledent AG
EC Certificate
Coltène/Whaledent AG MDSAP Certificate
ISO 13485 Certificate
EU MDR Certificate
Coltène/Whaledent GmbH + Co. KG
EN ISO 13485
ISO 13485 : 2016
EC Design Examination Certificate haemostatic gelatine sponge
Quality System root canal filling materials, paper points, aspirator tips, medicated gelatin sponges, root canal files, dental rotary handpiece with engine
Quality System sterile covers, sterile sleeves for tubes

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