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10030001/20030001/30030000

by Axess Vision Technology EUDAMED510(k)

Active United States and European Union

Ref 10030001/20030001/30030000Model Broncoflex Agile, Broncoflex Vortex and Screeni

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3664977EMDNZ12020802SPPBD Basic UDI-DIDate23 Oct 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK212886 Date16 Feb 2022IssuedStatusActive

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
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k)

Model / Reference
Broncoflex Agile, Broncoflex Vortex and Screeni, 10030001/20030001/30030000
Primary DI / UDI-DI
03664977000097
Medical Purpose
Broncoflex Agile & Broncoflex Vortex: This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni) and to be used with endotherapy accessories and instruments. The pulmonary tract include the organs, tissues and subsystems represented by the nasal passages, trachea and bronchial tree beyond the primary bronchi. The video-bronchoscope is inserted via the oral or nasal route. The Broncoflex should not be used for any purpose other than that described herein. Screeni: This product was developed by the company Axess Vision and is exclusively reserved for the endoscopic examinations claimed in the manual of the endoscope used (see list of compatible devices). The Screeni is used for viewing the lungs and airways by means of a single-use endoscope. The Screeni should not be used for any purpose other than that described herein.

Manufacturer details

EUDAMED SRN
FR-PR-000038039

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