6117700CE01
| EU Quality Management System Certificate | |
| Manufacturer: | Fairy Medical Electrics (Jiaxing) Co., Ltd. West Zone of 2nd Floor, Building A No.2 Caohejing RD., Haichang Street, Haining City 314499 Jiaxing City, Zhejiang Province China SRN ID.: CN-MF-000026902 |
| VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES, (Z11039080, class IIb) | |
| Group of Devices: X-ray Collimator | Intended Purpose: The device is designed to be used with a radiological system producing ionizing radiation for medical use. It is designed to be used to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam as an accessory of an X-ray system in a professional healthcare facility environment. And the x-ray collimator is also used to provide patient protection by eliminating exposure to non-target body areas. The device is not intended to be used in fluoroscopy applications. |