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LithoVue M0068010000

by Boston Scientific

Ref M0068010000

LithoVue M0068010000 is a device classified as Class IIa in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 25 Oct 2025 (Basic UDI-DI 01915060000000000000115MJ) and listed in FDA GUDID since 15 Apr 2019 (UDI-DI 08714729974789), 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 Number01915060000000000000115MJ Basic UDI-DI 08714729974789UDI-DIDate25 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729974789 UDI-DI Date15 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000115MJ registered 25 Oct 2025 Active
  • FDA GUDID UDI-DI 08714729974789 listed 15 Apr 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08714729974789
  2. Registered EUDAMED 01915060000000000000115MJ

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  • Withdrawn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
LithoVue™ EUDAMED
LithoVue GUDID
Generic name
Flexible video ureteroscope, single-use
Device name
LithoVue Touch PC
Model / Ref / Catalog
M0068010000
Primary DI / UDI-DI
08714729974789
Basic UDI-DI
01915060000000000000115MJ
FDA product code
FGB
EMDN code
Z12020780 Genitourinary endoscopy instruments - hardware accessories
GMDN term
Flexible video ureteroscope, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
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: Flexible video ureteroscope, single-use

Similar devices in this category

Other devices filed under GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Boston Scientific

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Properties

  • Reprocessed single-use device
  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (21, all answered No)