Thrombectomy Suction Catheter - India CDSCO Medical Device Registration

Thrombectomy Suction Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000108_09884a24a970b27bd67db65902960880_17361ff8719d07aeb8dea7fe5711ad88. 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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CDSCO Registered

Class Class D

Thrombectomy Suction Catheter

UID: IMP/MD/2021/000108_09884a24a970b27bd67db65902960880_17361ff8719d07aeb8dea7fe5711ad88

Brand Name

SOFIA EX

License Holder

Faith Biotech Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The SOFIA™ Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA™ Catheter can be used to facilitate introduction of diagnostic or therapeutic agents. The SOFIA™ Catheter is not intended for use in coronary arteries. Moreover, the SOFIA™ Catheter is intended for use in removal/aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neuro vasculatures

Class D

Brand: Flow Re-Direction Endoluminal Device

Class D