Quality and compliance are fundamental to everything we do at Viscot Medical. We are committed to manufacturing exceptional, safe and reliable disposable and re-usable medical devices that meet both domestic U.S. and international standards.
All Viscot Medical products are classified as Class I Medical Devices and comply with all necessary regulatory requirements for the appropriate designation.
Below you will find the following documents to assure our quality standards:
- FDA Establishment Registration
- ISO Certification
- MDR Certificate / CE Certificate BSI
- Declarations of Conformity
Our Latex Free statement is located here.