Fraxion - India CDSCO Medical Device Registration
Fraxion is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001235_1a30f8881766694805b95089f935244b_8d692fb145a7436eafd31dbaa9dff878. This device is marketed under the brand name BlueBAG. The license holder is ELEKTA MEDICAL SYSTEMS INDIA PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
BlueBAG
License Holder
ELEKTA MEDICAL SYSTEMS INDIA PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
The Fraxion is intended to use for immobilization, positioning, and repositioning during Stereotactic Radiotherapy (BlueBAG) in all parts of the brain and head in a Linear Accelerator environment.
