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 | |
| Status | Valid |