Silhouette Soft achieves EU MDR CertificationSilhouette Soft achieves EU MDR Certification

Silhouette Soft achieves EU MDR Certification

Silhouette Soft® – The technologically advanced performance suture for highly skilled practitioners

Silhouette Soft® is the state of the art suture that produces a natural, sculpted, non-surgical thread lift. Silhouette Soft® is made with unique micro-cones that anchor and suspend tissue offering dual, long lasting action by promoting collagenesis.

Sinclair Pharma Ltd announced that it has received EU MDR Class III Certification from Bsi (2797) for the Silhouette Soft® family. This continues to demonstrate the safety and effectiveness of the Silhouette Soft range of products and ensures compliance with the highest standards demanded by the MDR regulatory framework.

Silhouette Soft® is a resorbable sterile implantable single-use device intended to be used in adult patients for facial and neck reconstruction in the treatment of facial morphological asymmetry and ptosis.

Sinclair’s Chief Marketing Officer, Philip Norstrand, confirmed the announcement, "Sinclair prides itself on delivering innovative and unique solutions to directly address the needs and challenges of our customers. This certification validates our on-going focus to provide products that are backed by extensive research and testing”.

The company is delighted that its Global Regulatory Team has achieved this significant landmark for its Silhouette Soft® product family which is distributed and sold worldwide. With this certification, our customers can be confident that they are using the most advanced and safe suture product available on the market.


Media Contacts: Philip Norstrand, Emily Roberts,

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