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LungVision System Core

by Bodyvision Medical, Ltd.

Ref LV1055001Model CORE

LungVision System Core (LV1055001) is a virtual bronchoscopic navigation PACS software (EU MDR Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Bodyvision Medical, Ltd., registered in EUDAMED on 24 Mar 2026 (Basic UDI-DI 7290017652BVMSYSTEM22) and listed in FDA GUDID since 29 May 2019 (UDI-DI 07290017652030), active as of 25 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7290017652BVMSYSTEM22 Basic UDI-DI 07290017652030UDI-DIDate24 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290017652030 UDI-DI Date29 May 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7290017652BVMSYSTEM22 registered 24 Mar 2026 Active
  • FDA GUDID UDI-DI 07290017652030 listed 29 May 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07290017652030
  2. Registered EUDAMED 7290017652BVMSYSTEM22

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
LungVision EUDAMED
LungVision System GUDID
Generic name
Virtual bronchoscopic navigation PACS software
Model / Ref / Catalog
Core, LV1055001
Primary DI / UDI-DI
07290017652030
Basic UDI-DI
7290017652BVMSYSTEM22
Direct marketing DI
07290017652030
FDA product code
LLZ
EMDN code
Z119007 Image acquisition modules
GMDN term
Virtual bronchoscopic navigation PACS software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Virtual bronchoscopic navigation PACS software

Similar devices in this category

Other devices filed under VARIOUS BIOIMAGING AND RADIOTHERAPY INSTRUMENTS.

Other devices from Bodyvision Medical, Ltd.

See all devices from Bodyvision Medical, Ltd. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)