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LiDCO Ltd Li10778

by Lidco Limited

Ref Li10778Model GCX RSVH

LiDCO Ltd Li10778 is a device classified as Class I in the EU and Class II in the US made by Lidco Limited, registered in EUDAMED on 30 Jan 2023 (Basic UDI-DI 506011052000Z7T5C01V000CK), cleared under FDA 510(k) K122247 on 20 Mar 2013 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 05060110521494), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122247

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506011052000Z7T5C01V000CK Basic UDI-DI 05060110521494UDI-DIDate30 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05060110521494 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK122247 Date20 Mar 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506011052000Z7T5C01V000CK registered 30 Jan 2023 Active
  • FDA 510(k) K122247 decided 20 Mar 2013 Active
  • FDA GUDID UDI-DI 05060110521494 listed 13 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K122247
  2. Listed FDA GUDID 05060110521494
  3. Registered EUDAMED 506011052000Z7T5C01V000CK

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  • Withdrawn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
Pole/Rail Clamp to VESA Assembly EUDAMED
LiDCO Ltd GUDID
Generic name
General-purpose multi-parameter bedside monitor
Device name
Roll Stand, Variable Height
Model / Ref / Catalog
Li10778, GCX RSVH
Primary DI / UDI-DI
05060110521494
Basic UDI-DI
506011052000Z7T5C01V000CK
510(k) Number
FDA product code
DXG
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
General-purpose multi-parameter bedside monitor
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1435
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 I
GUDID
Class II

Related devices

Category: General-purpose multi-parameter bedside monitor

Cleared under the same submission (K122247)

and 8 more cleared under K122247

Other devices from Lidco Limited

  • LiDCO Li11083

    Class II

  • LiDCO Ltd Li10707

    Class II

  • LiDCO Ltd Li10395

    Class II

  • LiDCO Ltd CM 50-001-01

    Class II

See all devices from Lidco Limited →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)