Notified Bodies for medical devices
Kiwa Cermet Italia (NB 0476) in Italy, Kiwa Belgelenddirme Hizmetleri (NB 1984) in Turkey, and DARE!! Services (NB 1912) in The Netherlands, are the Notified Bodies within the Kiwa Group, boasting a wide and in-depth experience in medical devices certification, with thousands of products already certified.
Kiwa Cermet Italia - NB 0476
Kiwa Cermet Italia, designated by the Italian Ministry of Health, provides worldwide conformity assessment services according to the Medical Device Regulation 2017/745/EU (MDR) and the Medical Device Directive 93/42/EEC (MDD) for an almost full scope of designation. The scope details are reported in the Nando Database of the European Commission.
Kiwa Cermet Italia is also a Certification Body accredited by ACCREDIA, for management system certification according to the scheme ISO 13485 and other international standards.
Kiwa Belgelenddirme Hizmetleri - NB 1984
Kiwa Belgelenddirme Hizmetleri, designated by the Turkish Ministry of Health, provides worldwide conformity assessment services according to the Medical Device Directive 93/42/EEC (MDD) for an almost full scope of designation. The scope details are reported in the Nando Database of the European Commission.
Kiwa Turkey is also an Accredited Body by TURKAK for management system certification according to ISO 9001 and ISO 13485 standards.
DARE!! Services - NB 1912
Kiwa DARE !! Services, part of Kiwa since March 2021, designated by the Dutch Ministry of Health, Welfare and Sport (VWS), provides worldwide conformity assessment services according to the Medical Devices Regulation (EU) 2017/745 (MDR) and the Medical Device Directive 93/42/EEC (MDD). 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.