6126956CE01

6126956CE01
EU Quality Management System Certificate
Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and II
Manufacturer:Changzhou Sifary Medical Technology Co., Ltd.
No. 26 Yandanghe Road, Xinbei District
213000 Changzhou, Jiangsu
China
SRN ID.: CN-MF-000010405
device(s) / groups of device(s):
Non-active non-implantable instruments (MDN1208, class IIa)
Device Name: Endodontic Files
INTRAORAL X-RAY INSTRUMENTS (Z110304, class IIb)
Group of Devices: Hand-held Dental X-ray Systems Intended Purpose: It is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.
Active non-implantable imaging devices utilising ionizing radiation (MDA0201, class IIa)
Group of Devices: Intraoral Digital Imaging Sensors
StatusValid