X-Ray Machine - India CDSCO Medical Device Registration

X-Ray Machine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000264_ec02968487877db8d2077c15cfbec622_f00d5892d93a18a35a138496d30bb221. This device is marketed under the brand name Affiniti Diagnostic Ultrasound System. The license holder is Philips India Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

X-Ray Machine

UID: MFG/MD/2021/000264_ec02968487877db8d2077c15cfbec622_f00d5892d93a18a35a138496d30bb221

Brand Name

Affiniti Diagnostic Ultrasound System

License Holder

Philips India Limited

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The Veradius Unity device is intended to be used and operated by: adequately trained, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, radiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (Affiniti Diagnostic Ultrasound System), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, in sterile as well as non-sterile environments, in a variety of procedures. Applications • Orthopedic • Neuro • Abdominal • Vascular • Thoracic • Cardiac

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