Legal notice

Website operator

SYLKE, Inc.
4150 Regents Park Row, Suite 300
La Jolla, CA 92037
United States
Phone: +1 858 727 9553
Email: info@sylke.com
Website: www.sylke.com

Trademarks

SYLKE® and SYLKE MD® are registered trademarks of SYLKE, Inc. All other trademarks are the property of their respective owners.

Patents

SYLKE® products are protected by patents. See www.sylke.com/pages/patents.

Product and regulatory information

SYLKE® Skin Closure is a Class I, 510(k)-exempt device in the United States (21 CFR 880.5240). In the European Union it is CE marked (CE 2862).

EU Authorized Representative: Emergo Europe, Westervoortsedijk 60, 6827 AT, Arnhem, The Netherlands (SRN: NL-AR-000000116)
EU Importer: MedEnvoy Global B.V., Prinses Margrietplantsoen 33, Suite 123, 2595 AM The Hague, The Netherlands
Switzerland Authorized Representative & Importer: MedEnvoy Switzerland, Gotthardstrasse 28, 6302 Zug, Switzerland
UKRP & UK Importer: MedEnvoy UK Limited, 167-169 Great Portland Street, 5th Floor, London, W1W 5PF, United Kingdom

Indications, labeling, and availability vary by country. Always refer to the Instructions for Use for your region: United States, European Union, International.

Medical information

Information on this website is provided for general informational purposes and is not medical advice or a substitute for the professional judgment of a healthcare provider.

Reporting a serious incident

Please report a serious incident occurring in relation to a SYLKE® device to SYLKE, Inc. at quality@sylke.com and to your local regulatory authority.

Paper Instructions for Use

A paper copy of the Instructions for Use is included in every box. Additional paper copies can be requested free of charge, including shipping, via compliance@sylke.com.