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Kendall 33105E

by Cardinal Health 200, LLC

Ref 33105EModel EMEA, 5 lead set

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063014000000000000003967A Basic UDI-DI 10192253062908UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10192253062908 UDI-DI Date14 Jul 2023ListedStatusListed 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  • Withdrawn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 lead set, single-use
Device Name
EMEA, 5 lead set
Model / Ref / Catalog
33105E, EMEA, 5 lead set
Primary DI / UDI-DI
10192253062908
Basic UDI-DI
063014000000000000003967A
FDA Product Code
IKD
EMDN Code
K02010203 Electrosurgery connection cables, single-use
GMDN Term
Electrocardiographic lead set, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.1175
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 10 Feet

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Category: Electrocardiographic lead set, single-use

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Properties

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

Other properties (20)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No