Intraluminal Support Device - India CDSCO Medical Device Registration
Intraluminal Support Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000108_ea21d8e78ae044752b24da1104645e60_bc752b9feb08a61e82dc59d40b86bf7f. This device is marketed under the brand name SOFIA EX. The license holder is Faith Biotech Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
SOFIA EX
License Holder
Faith Biotech Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The FRED X System is intended for endovascular embolization of intracranial neurovascular aneurysms. The FRED X System may also be used with embolic coils for the treatment of intracranial neurovascular lesions.
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