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Dolphin Sutures Recertified with CE

Dolphin Sutures is now accredited with CE for the third time since 2008. We have received this certification from DNV-GL PRESAFE AS, notified body number 2460 under NORWEGIAN Accreditation. DNV GL Presafe is a global testing and certification company specialised in the medical device industry and ensures efficient and reliable compliance, assessment and guidance services based on EU directives and international safety and quality standards. 

 

A brief about the CE Certification: CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area. The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards. We see the letters “CE” on many products, this marking means Conformity with Europe, demonstrating that the products have been audited in terms of minimum health, safety and environmental requirements. CE marking also indicates fair competition among manufacturers, enforces accountability and conformity with same requirements. The CE marking is described as a trade passport as it enables the movement of products in the market.

 

CE Marking in Medical Devices: The CE marking shows that medical device manufacturers meet the quality, safety and efficacy of the product to ensure the standards of performance as defined by the Directives. Before placing the medical device in the market, the executive order stipulates CE mark is required on medical devices.