Adapting versatile
polymers to improve
surgical outcomes
and patient recovery

VIVOSORB®

Regulatory

Polyganics' quality system complies to ISO 13485, and dictates quality management standards and requirements for a comprehensive management system for design, manufacturing and distribution of medical devices. Polyganics also complies to the USA FDA 21 CFR 820 corresponding subparts. The Polyganics' Quality Management System is ISO13485:2003 certified by Dekra Certification BV.

Classification details Vivosorb®

European market Device class: Class III
EC Notified Body  Identification number: 0344
Notified body Dekra
   
US market

Device Class 2; FDA 510(k) number:

K042811

Product Code FTL
Regulation number 21 CFR 878.3300
Medical Specialty General and Plastic Surgery
Owner/Operator Polyganics
Owner/Operator number 9057333
Establishment registration number 3004504732