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Fiagon GmbH

Germany·DE-MF-000010763

Last updated September 17, 2026

Information

Country: Germany
Address: 23b, Neuendorfstr., Hennigsdorf, Germany
Website: www.fiagon.de
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +49 3302 201 21 10
PRRC Contact: Magdalena Giba
EUDAMED SRN: DE-MF-000010763
FDA FEI Number: 3010313588
DUNS Number: 312623008

Catalogue (97)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Fiagon Navigation Unit	1	FDA UDI	Class II	Unknown
Navigation Headrest Flat	1	FDA UDI	Class II	Active
Navigation Headrest Trumpf	1	FDA UDI	Class II	Unknown
Localizer Bone Anchor	1	FDA UDI	Class II	Unknown
PointerTube Sinus Frontalis	1	FDA UDI	Class II	Unknown
Fiagon Navigation Unit Cranial	1	FDA UDI	Class II	Unknown
FlexPointer 1.5 Cranial	1	FDA UDI	Class II	Active
4K Navigation Unit Cube4D	E 01 1106-4K/8	EUDAMEDFDA UDI	Class IIa	Active
PointerShell 3mm	E 01 2902	EUDAMEDFDA UDI	Class I	Active
Navigation Sensor FlexArm	N 01 1012	EUDAMEDFDA UDI	Class IIa	Active
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D	K211291	FDA 510(k)	Class II	Active
Guidewire 0.6 Single Use	K161940	FDA 510(k)	Class II	Active
GuideWire	K160369	FDA 510(k)	Class II	Active
FlexPointer 1.5 mm	K150473	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
VenSure Balloon Device, VenSure Nav Balloon Device	K201472	FDA 510(k)	Class I	Active
VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System	K230065	FDA 510(k)	Class II	Active
Fiagon Navigation – PointerTube Straight and PointerTube Keat	K163416	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
PointerShell Universal, PointerShell LS	K160479	FDA 510(k)	Class II	Active
FlexPointer 1.5 Single Use, FlexTube 3 Single Use	K200041	FDA 510(k)	Class II	Active
The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer, Venterapointer, Guidewire, Pointershell	K141456	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
Localizer Bone Anchor C-Type	E 01 2204 C	EUDAMED	Class IIa	Active
Adapter for Flexsensor	N 01 1949	EUDAMEDFDA UDI	Class I	Active
RIWOtrack Clipsensor	N 01 2951	EUDAMEDFDA UDI	Class I	Active
MultiPad	A 01 1406-RW	EUDAMEDFDA UDI	Class I	Active
VirtuEye	E 01 1430	EUDAMEDFDA UDI	Class I	Active
Adhesive Pad	E 00 3001	EUDAMEDFDA UDI	Class I	Active
FlexTube 4mm	E 01 2106	EUDAMEDFDA UDI	Class IIa	Active
Adapter for Clipsensor stenosis	N 01 1969	EUDAMED	Class I	Active
FlexPointer	E 01 2002	EUDAMEDFDA UDI	Class IIa	Active
FlexArm Adapter for siderail	E 01 1905	EUDAMED	Class I	Active
VirtuEye Pro	E 10 1440	EUDAMED	Class I	Active
RIWOtrack Flexsensor	N 01 2950	EUDAMEDFDA UDI	Class IIa	Active
PointerShell 5mm	E 01 2901	EUDAMEDFDA UDI	Class I	Active
FlexTube 3mm	E 01 2104	EUDAMEDFDA UDI	Class IIa	Active
Navigation Unit Cube4D	E 01 1106-HD/8	EUDAMEDFDA UDI	Class IIa	Active
Navigation Headrest Horseshoe	E 01 1005	EUDAMED	Class I	Active
Adapter for Clipsensor	N 01 1959	EUDAMEDFDA UDI	Class I	Active
Navigation Headrest Universal	E 01 1003	EUDAMEDFDA UDI	Class I	Active
Navigation Sensor	A 01 1000	EUDAMEDFDA UDI	Class IIa	Active
RIWOtrack Navigation Unit Cube4D	E 01 1106 -4K/8 -RW	EUDAMEDFDA UDI	Class IIa	Active
Localizer Adhesive Pad C-Type	E 01 2202 C	EUDAMEDFDA UDI	Class IIa	Active
PointerShell 4mm	E 01 2900	EUDAMEDFDA UDI	Class I	Active
Localizer K-Wire	N 01 2213-RW	EUDAMEDFDA UDI	Class IIa	Active
Navigation Headrest Flat	E 01 1001	EUDAMED	Class I	Active
MapperBridge	N 01 2701-RW	EUDAMEDFDA UDI	Class I	Active
RIWOtrack Clipsensor stenosis	N 01 2954	EUDAMED	Class I	Active
PointerTube Kennedy	E 01 2108	EUDAMEDFDA UDI	Class IIa	Active

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