Navigation System - India CDSCO Medical Device Registration

Navigation System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000663_2f426258680fdc31c45fba008b25426d_f35db39cd71403386b5563916bfd1f9b. This device is marketed under the brand name Fiagon. The license holder is Smith & Nephew Healthcare Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Navigation System

UID: IMP/MD/2023/000663_2f426258680fdc31c45fba008b25426d_f35db39cd71403386b5563916bfd1f9b

Brand Name

Fiagon

License Holder

Smith & Nephew Healthcare Pvt. Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model of the anatomy.