HSA · registration DE0510178Fiagon Cube 4D Navigation System
- Registration number
- DE0510178
- Model name
- 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
- 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
- Registration date
- December 23, 2024
- Source update date
- January 14, 2026
- Risk class
- Class B
- Product owner
- Fiagon GmbH
- Registrant / registration holder
- SMITH & NEPHEW PTE. LIMITED
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.
- Product owner address
- Neuendorfstr. 23 b, 16761 Hennigsdorf, Deutschland, Germany
- Registrant address
- 29 MEDIA CIRCLE, #06-05, ALICE@MEDIAPOLIS, Singapore 138565
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.