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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.