Skip to content

Broncoflex Agile; Product Reference: 20030001, Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001

by Axess Vision Technology United States EUDAMED510(k)

510(k) K202180 Product code EOQ

Overview

The Broncoflex Agile, Broncoflex Vortex, and Screeni are medical devices designed for use in ear, nose, and throat procedures. These devices are part of a product line with specific product references for each model.

The devices are supplied with regulatory authorizations including FDA 510K, MDD, and MDR. They are manufactured by Axess Vision Technology in Joué-Lès-Tours, France, and are intended for single-use or reusable applications depending on the specific model.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK202180 Date22 Oct 2020ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 25 Oct 2026

510(k) Number
FDA Product Code
EOQ
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Other devices from Axess Vision Technology

Questions

  • What are the Broncoflex Agile, Broncoflex Vortex, and Screeni devices used for?

    These medical devices are designed for use in ear, nose, and throat procedures. Each model has a specific product reference number indicating its unique configuration within the product line.

  • Are these devices single-use or reusable?

    The devices may be either single-use or reusable depending on the specific model. The Broncoflex Agile, Broncoflex Vortex, and Screeni each have different intended applications that determine their use designation.

  • What regulatory authorizations do these devices have?

    The devices are supplied with FDA 510K, MDD, and MDR regulatory authorizations. These indicate they meet specific regulatory requirements for medical devices in their respective markets.

  • Where are these devices manufactured?

    The devices are manufactured by Axess Vision Technology in Joué-Lès-Tours, France. The manufacturing facility is located at Zone De La Liodière 6, Rue De La Flottière.

Properties & raw data

Show properties, registry sources and raw records

Sources (2)

  • FDA 510(k) K202180 24 fields · synced 25 Oct 2026
  • EUDAMED 1 fields · synced 19 May 2026