VenSure Nav Balloon Dilation System

FDA UDI

Class I (US FDA UDI)

by Fiagon GmbH

Identity

Trade Name: VenSure Nav Balloon Dilation System FDA UDI
Generic Name: Nasal/paranasal balloon catheter FDA UDI
Device Name: Balloon Dilation system as set including navigated Balloon dilation device with bending tool and Inflation device with tubes, FDA UDI
Model / Reference: 1 FDA UDI
Description: Balloon Dilation system as set including navigated Balloon dilation device with bending tool and Inflation device with tubes, FDA UDI

Identifiers

Catalog Number: E 01 3546 FDA UDI
Primary DI / UDI-DI: 04260759931260 FDA UDI
FDA Product Code: LRC FDA UDI
PNZ FDA UDI
GMDN Term: Nasal/paranasal balloon catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
874.4180 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nasal/paranasal balloon catheter

VenSure Nav Balloon Dilation System by Fiagon GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nasal/paranasal balloon catheter.

XprESS Ultra — Stryker Corp. · Class I
RELIEVA ULTIRRA — ACCLARENT, INC. · Class I
RELIEVA SPINPLUS NAV — ACCLARENT, INC. · Class II
NuVent ™ — MEDTRONIC XOMED, INC. · Class I
NuVent ™ — MEDTRONIC XOMED, INC. · Class I
RELIEVA ULTIRRA NAV — ACCLARENT, INC. · Class I
BB 8 Sinus Dilation Kit — Excelent, Inc. · Class I
NuVent ™ — MEDTRONIC XOMED, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Fiagon GmbH

Sources (1)

FDA UDI 3121252d-c942-47e9-adad-621088220b06 34 fields · synced May 30, 2026