ISO 9001:2015 CERTIFICATE

UNI EN ISO 9001:2015 CERTIFICATE

ISO 13485:2016 CERTIFICATE

UNI CEI EN 13485:2016 CERTIFICATE

CE CERTIFICATE 11971/2 

CE CERTIFICATE QCT-0125-19
TISSUE-C & CARRY-C

DESIGN EXAMINATION
EPG-0232-19 – CARRY-C

DESIGN EXAMINATION
EPG-0233-19 – TISSUE-C

Audit History

  • 2019

  • UKRAINE – Ukrainian Center for Medical Certification and prognostication
  • USA – FDA
  • ITALY  – Notified Body n. 0546 for UNI EN ISO 9001:2015 certification & UNI CEI EN ISO 13485:2016 certification + medical device CE certification
  • 2018

  • UKRAINE – Ukrainian Center for Medical Certification and prognostication
  • CHINA – CFDA
  • UKRAINE – ECOHYNTOX Conformity Assessment Body
  • ITALY – Notified Body n. 0546 and n. 0373 for UNI EN ISO 9001:2015 certification & UNI CEI EN ISO 13485:2016 certification
  • 2017

  • G.C.C. – SGH_ Saudi Arabia
  • UKRAINE – Ukrainian Center for Medical Certification and prognostication
  • BRAZIL – Brazilian Health Surveillance Agency
    (ANVISA)
  • ITALY – Notified Body n. 0546 for UNI EN ISO 9001:2008 certification & UNI CEI EN ISO 13485:2012 certification
    Notified body n. 0373 for Class III Medical Device CE certification
  • 2016

  • ITALY – Notified Body n. 0546 for UNI EN ISO 9001:2008 certification & UNI CEI EN ISO 13485:2012 certification