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LiDCO Ltd HM 38-02 MODULE

by Lidco Limited

Ref HM 38-02 Assembly

LiDCO Ltd HM 38-02 MODULE is a device classified as Class IIa in the EU and Class II in the US made by Lidco Limited, registered in EUDAMED on 14 Dec 2022 (Basic UDI-DI 506011052000Z7T4C01V000BY), cleared under FDA 510(k) K131048 on 28 Aug 2013 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 05060110521241), 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) K131048

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 Number506011052000Z7T4C01V000BY Basic UDI-DI 05060110521241UDI-DIDate14 Dec 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number05060110521241 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK131048 Date28 Aug 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 506011052000Z7T4C01V000BY registered 14 Dec 2022 Active
  • FDA 510(k) K131048 decided 28 Aug 2013 Active
  • FDA GUDID UDI-DI 05060110521241 listed 13 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K131048
  2. Listed FDA GUDID 05060110521241
  3. Registered EUDAMED 506011052000Z7T4C01V000BY

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  • Withdrawn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
LiDCO CNAP Assembly EUDAMED
LiDCO Ltd GUDID
Generic name
General-purpose multi-parameter bedside monitor
Model / Ref / Catalog
HM 38-02 Assembly EUDAMED
HM 38-02 MODULE GUDID
Primary DI / UDI-DI
05060110521241
Basic UDI-DI
506011052000Z7T4C01V000BY
Direct marketing DI
05060110521241
510(k) Number
FDA product code
DXG
EMDN code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN term
General-purpose multi-parameter bedside monitor
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1435
System or procedure pack
System which is a device in itself
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
HM 38-02 Assembly
GUDID
HM 38-02 MODULE
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: General-purpose multi-parameter bedside monitor

Cleared under the same submission (K131048)

and 8 more cleared under K131048

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    Class II

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  • LiDCO Ltd CM 50-001-01

    Class II

See all devices from Lidco Limited →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)