Fiagon Navigation System - HSA Registration DE0505011
Access comprehensive regulatory information for Fiagon Navigation System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505011 and owned by Fiagon GmbH. The device was registered on October 08, 2020.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: Cranial biopsies, Tumor resections, Craniotomies/Craniectomies, Skull base procedures, Thalamotomies/ Pallidotomies. Spinal Procedures; Spinal implant procedures, such as pedicle screw placement. ENT Procedures; Transphenoidal procedures, Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations,Turbinate resections, and Frontal sinusotomies.