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Kendall 31.1245.21

by Cardinal Health 200, LLC

Ref 31.1245.21Model Electrode, Foam, Hydrogel, Snap, Monitoring

Kendall 31.1245.21 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 9 Oct 2026 (Basic UDI-DI 063014000000000000003386U) and listed in FDA GUDID since 8 Mar 2022 (UDI-DI 20192253016854), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063014000000000000003386U Basic UDI-DI 20192253016854UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20192253016854 UDI-DI Date8 Mar 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 063014000000000000003386U registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 20192253016854 listed 8 Mar 2022 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 20192253016854
  2. Registered EUDAMED 063014000000000000003386U

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  • Withdrawn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
Device name
Electrode, Foam, Hydrogel, Snap, Monitoring
Model / Ref / Catalog
31.1245.21, Electrode, Foam, Hydrogel, Snap, Monitoring
Primary DI / UDI-DI
20192253016854
Basic UDI-DI
063014000000000000003386U
Unit of use DI
10192253016857
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 · 1 field differs

FieldEUDAMEDGUDID
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)