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Kendall ES40281

by Cardinal Health 200, LLC

Ref ES40281-Model Cloth Electrodes Repositionable Conductive Adhesive Hydrogel

Kendall ES40281 (ES40281-) is a device classified as Class I in the EU and Class II in the US made by Cardinal Health 200, LLC, registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI 063014000000000000003366Q) and listed in FDA GUDID since 23 Nov 2020 (UDI-DI 20192253017912), active as of 23 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063014000000000000003366Q Basic UDI-DI 20192253017912UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20192253017912 UDI-DI Date23 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 063014000000000000003366Q registered 17 Sep 2026 Active
  • FDA GUDID UDI-DI 20192253017912 listed 23 Nov 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 20192253017912
  2. Registered EUDAMED 063014000000000000003366Q

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  • Withdrawn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
Kendall
Generic name
Electrocardiographic electrode, single-use
Model / Ref / Catalog
Cloth Electrodes Repositionable Conductive Adhesive Hydrogel, ES40281-, ES40281
Primary DI / UDI-DI
20192253017912
Basic UDI-DI
063014000000000000003366Q
Unit of use DI
10192253017915
FDA product code
DRX
EMDN code
C020501 ECG electrodes
GMDN term
Electrocardiographic electrode, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2360
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Cloth Electrodes Repositionable Conductive Adhesive Hydrogel
ES40281-
GUDID
ES40281
Device classEUDAMED
Class I
GUDID
Class II

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.

Related devices

Category: Electrocardiographic electrode, single-use

Similar devices in this category

Other devices filed under ECG ELECTRODES.

Other devices from Cardinal Health 200, LLC

See all devices from Cardinal Health 200, LLC →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)