Regulatory Compliance

Manufacture/Device Registrations

• FDA Medical Device Establishment Registration, Registration Number: 2936330

• State of California Department of Public Health, Food and Drug Branch, Device Manufacturing License number: 45088

• Australian TGA (Therapeutic Goods Administration) Device Registration

• Health Canada Device Registration

Lloyd's Register Quality Assurance

Scholten Surgicals Quality Management System is approved by Lloyd's Register Quality Assurance to the following Quality Management System Standards:

• ISO 13485:2003 Certificate of Approval

• UKAS United Kingdom National accreditation Mark

• SCC Accredited - Standards Council of Canada Quality System Accredited

• View Certificate of Approval

Medical Devices Directive 93/42/EEC Conformity Certificate

• CE Marked Novatome™ Endomyocardial Biopsy Forceps

• View Approval of Conformity Certificate

Global Regulatory Representative

• Australia - Sponsor Representative
  Emergo Australia, Sydney, Australia
  Telephone: +61.2.9006.1662
  http://www.EmergoGroup.com

• Emergo Europe, The Hague, Netherlands
  Telephone: +31.70.345.8570A
  http://www.EmergoGroup.com

  Europe - Authorized Representative

* All Viewable Certifications require a PDF reader, You can download adobe acrobat for free using this link.