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Fiagon Cube 4D Navigation System - HSA Registration DE0510178

Access comprehensive regulatory information for Fiagon Cube 4D Navigation System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510178 and owned by Fiagon GmbH. The device was registered on December 23, 2024.

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.

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CLASS B
DE0510178
Fiagon Cube 4D Navigation System
HSA Registration Number: DE0510178
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Product Description

The Cube 4D Navigation System with its components and accessories is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Cube 4D 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 paranasal sinuses, mastoid anatomy, skull base and the skull, can be identified relative to a CT or MR based model of the anatomy.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0510178
Registration Date
December 23, 2024
Retention Due Date
December 22, 2025
Product Owner
Short Name
Fiagon GmbH
Address
Neuendorfstr. 23 b, 16761 Hennigsdorf, Deutschland, GERMANY
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565 29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #06-05, SINGAPORE 138565
Model Information
Model Name(s)
Navigation Sensor Adhesive pad Navigation headrest Universal Cube 4D Navigation System VirtuEye Flexarm adapter for siderail FlexPointer RegistrationPointer FlexPointer 1.5mm FlexTube 3mm Flex Tube 4mm PointerTube Keat PointerTube Kennedy Localizer Adhesive pad C-Type Localizer Bone Anchor C-Type PointerShell 4mm PointerShell 5mm PointerShell 3mm PointerShell Universal Sinus navigation software
Model Identifier(s)
A 01 1000 E 00 3001 E 01 1003 E 01 1106 -HD/8 E 01 1430 E 01 1905 E 01 2002 E 01 2003 E 01 2004 E 01 2104 E 01 2106 E 01 2107 E 01 2108 E 01 2202 C E 01 2204 C E 01 2900 E 01 2901 E 01 2902 E 01 2904 S 01 4000