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Broncoflex Vortex

by Axess Vision Technology United States EUDAMEDGUDID

Ref 10030001, 10030001 Model Vortex, 10040001

Product code EOQEMDN Z12020802

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-03664977010034 Basic UDI-DIDate9 May 2022RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-03664977010034 Basic UDI-DIDate9 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number03664977010034 UDI-DIDate10 Dec 2020ListedStatusIn distribution

Coverage

2 jurisdictions

United 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 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 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 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 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Flexible video bronchoscope, single-use
Device Name
Broncoflex™ 5.6/3.0 XFlo
Model / Ref / Catalog
Vortex, 10030001, 10040001
Primary DI / UDI-DI
03664977010034
Basic UDI-DI
B-03664977010034, 3664977EMDNZ12020802PF
Direct Marketing DI
03664977010034
510(k) Number
FDA Product Code
EOQ
EMDN Code
Z12020802 Video bronchoscopes
GMDN Term
Flexible video bronchoscope, single-use
Device Class
Class IIa EUDAMED
Class I EUDAMED
Class II GUDID
Regulation Number
874.4680
Market of Registration
France
Commercial Distribution
In Commercial Distribution
Size
Lumen/Inner Diameter — 2.8 Millimeter
Outer Diameter — 5.6 Millimeter
Length — 605 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000003039

Other devices from Axess Vision Technology

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (19)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED c0f1b352-1c88-4b3a-9073-2c07cc0c4b2f 61 fields · synced 22 Oct 2026
  • FDA UDI a3016bf5-c9b1-4a1f-8879-ea478b8714c8 37 fields · synced 29 May 2026
  • EUDAMED 03664977010034|3664977EMDNZ12020802PF 61 fields · synced 12 Oct 2026