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Kendall 22453

by Cardinal Health 200, LLC

Ref 22453-Model Foam Electrodes, Conductive Adhesive Hydrogel

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063014000000000000003286R Basic UDI-DI 20192253016663UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20192253016663 UDI-DI Date28 Feb 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Foam Electrodes, Conductive Adhesive Hydrogel, 22453-, 22453
Primary DI / UDI-DI
20192253016663
Basic UDI-DI
063014000000000000003286R
Direct Marketing DI
20192253016663
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 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
Foam Electrodes, Conductive Adhesive Hydrogel
22453-
GUDID
22453
Device ClassEUDAMED
Class I
GUDID
Class II

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No