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BFlex™ 2 Large 5.8

by Verathon Medical (Canada) ULC

Ref 0570-0424

BFlex 2 Large 5.8 (0570-0424) is a flexible video bronchoscope (EU MDR Class IIa; FDA Class II; FDA product code EOQ, Bronchoscope (Flexible Or Rigid)) made by Verathon Medical (Canada) ULC, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 087912300-0003JW), cleared under FDA 510(k) K191948 on 21 Aug 2019 and listed in FDA GUDID since 3 Apr 2023 (UDI-DI 00879123008572), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191948

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number087912300-0003JW Basic UDI-DI 00879123008572UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00879123008572 UDI-DI Date3 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK191948 Date21 Aug 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 087912300-0003JW registered 27 Oct 2026 Active
  • FDA 510(k) K191948 decided 21 Aug 2019 Active
  • FDA GUDID UDI-DI 00879123008572 listed 3 Apr 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K191948
  2. Listed FDA GUDID 00879123008572
  3. Registered EUDAMED 087912300-0003JW

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Bflex 2 Large 5.8 EUDAMED
BFlex™ GUDID
Generic name
Flexible video bronchoscope, single-use
Device name
Single Use Bronchoscopes
Model / Ref / Catalog
0570-0424, BFlex™ 2 Large 5.8
Primary DI / UDI-DI
00879123008572
Basic UDI-DI
087912300-0003JW
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 II GUDID
Regulation number
874.4680
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
0570-0424
GUDID
BFlex™ 2 Large 5.8
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Flexible video bronchoscope, single-use

Similar devices in this category

Other devices filed under VIDEO BRONCHOSCOPES.

Other devices from Verathon Medical (Canada) ULC

See all devices from Verathon Medical (Canada) ULC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)