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LungVision

by Body Vision Medical 4 variants

Ref LV2055020Model Bridge

LungVision (LV2055020) is a bronchoscopic catheter (EU MDR Class I; FDA Class II; FDA product code EOQ, Bronchoscope (Flexible Or Rigid)) made by Bodyvision Medical, Ltd., registered in EUDAMED on 17 Mar 2026 (Basic UDI-DI 7290017652BVMTOOLPN), cleared under FDA 510(k) K172955 on 26 Apr 2018 and listed in FDA GUDID since 12 Jul 2021 (UDI-DI 07290017652115), active as of 25 Oct 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172955

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290017652BVMTOOLPN Basic UDI-DI 07290017652115UDI-DIDate17 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290017652115 UDI-DI Date12 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172955 Date26 Apr 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 7290017652BVMTOOLPN registered 17 Mar 2026 Active
  • FDA 510(k) K172955 decided 26 Apr 2018 Active
  • FDA GUDID UDI-DI 07290017652115 listed 12 Jul 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K172955
  2. Listed FDA GUDID 07290017652115
  3. Registered EUDAMED 7290017652BVMTOOLPN

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  • Withdrawn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
LungVision EUDAMED
LungVision Tool GUDID
Generic name
Bronchoscopic catheter
Model / Ref / Catalog
Bridge, LV2055020
Primary DI / UDI-DI
07290017652115
Basic UDI-DI
7290017652BVMTOOLPN
Direct marketing DI
07290017652115
510(k) Number
FDA product code
EOQ
EMDN code
R070199 Bronchopulmonary endoscopy probes, single-use - other
GMDN term
Bronchoscopic catheter
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.4680
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07290017652115: EUDAMED states Yes, FDA GUDID states No.

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

Manufacturer details

EUDAMED SRN
IL-MF-000021610
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under BRONCHOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE.

Other devices from Bodyvision Medical, Ltd.

See all devices from Bodyvision Medical, Ltd. →

Properties

  • Supplied sterile
  • Sterilise before use YesEUDAMEDNoGUDID
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)