Kiwa Notified Body for Medical Devices
Within the Kiwa group, Kiwa Cermet Italia (NB 0476), Kiwa Belgelenddirme Hizmetleri in Turkey (NB 1984) and Kiwa Dare Services (Netherlands) (NB 1912) boast a wide and in-depth experience as Notified Bodies in medical devices certification, with thousands of products already certified.
Kiwa Cermet Italia
Kiwa Cermet Italia is a Notified Body, authorized by the Italian Ministry of Health with the no. 0476, and is able to deliver services related to CE mark to a wide range of medical devices, including:
- non-active and non-implantable devices
- non-active implantable devices
- devices for the healing of injuries
- active, non-active and accessory dental devices
- devices for taking images and for monitoring physiological parameters
- sterile medical devices
- particular devices referred to in the Machinery Directive 2006/42/CE
Kiwa Cermet Italia is also a Certification Body accredited by ACCREDIA, according to the scheme ISO 13485.
Kiwa Dare Services, part of Kiwa since March 2021, has been appointed by the Dutch Ministry of Health, Welfare and Sport (VWS) as Notified Body for the Medical Devices Regulation (EU) 2017/745 (MDR). The designation is included in the Nando Database of the European Commission.
Kiwa Dare Services is also accredited for testing in accordance with the standard for medical equipment, EN-IEC 60601, for both EMC and safety aspects.
Kiwa Turkey provides worldwide conformity assessment services as Notified Body with NB number 1984. Kiwa Turkey is an Accredited Body by TURKAK for Management System Certification according to ISO 9001 and ISO 13485 standards.
More than twenty years of experience
Kiwa boasts a wide and in-depth experience as Notified Body from over 20 years in medical devices certification, with thousands of products already certified according to the MDD 93/42/EEC Directive and subsequent amendments.
For more information about our accreditations and notifications, please visit this page.
Member of TEAM-NB
Kiwa Cermet Italia and Kiwa Turkey are members of TEAM-NB, the European Association Medical devices of Notified Bodies.