6126956CE01
| Company | Changzhou Sifary Medical Technology Co., Ltd. | ||
| Address | No. 99 Qingyang Road, Xuejia County, Xinbei District 213000 Changzhou, Jiangsu China | ||
| Regulation | EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | ||
| Product | INTRAORAL X-RAY INSTRUMENTS (Z110304, class IIb) HyperLight Hand-held Dental X-ray System | ||
| 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. | |||
| Status | Valid | ||