YOU ARE ABOUT TO LEAVE A WEBSITE WHERE A MEDICAL DEVICE IS AVAILABLE FOR INVESTIGATIONAL USE UNDER THE OVERSIGHT OF THE UNITED STATES FOOD & DRUG ADMINISTRATION (FDA). THE PRODUCT IS INTENDED SOLELY FOR INVESTIGATIONAL PURPOSES AND HAS NOT YET RECEIVED FULL REGULATORY APPROVAL.
The website you will be redirected to features a commercial platform where the same medical device is available for commercial use with a CE mark. The CE marking indicates that the product complies with the essential requirements of relevant European Union (EU) and United Kingdom (UK) regulations, allowing its lawful placement on the market within the EU and UK.
By clicking “Proceed,” you acknowledge that you have read and understood this disclaimer. You recognize that the product’s regulatory status has shifted from investigational use under the FDA to commercial availability with a CE mark. You also agree that any decisions you make regarding the product will be based on its intended use and regulatory standing.
If you are uncertain about any aspect of the transition, it is advised to seek professional guidance and make informed decisions based on accurate information. Please proceed only if you are comfortable with these terms and understand the differences in regulatory status between US and EU/UK.
