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Kendall 33114N

by Cardinal Health 200, LLC

Ref 33114NModel Disposable Lead System, Direct Connect

Kendall 33114N is an electrocardiographic lead set (EU MDR Class I; FDA Class II; FDA product code IKD, Cable, Electrode) made by Cardinal Health 200, LLC, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 063014000000000000004076N) and listed in FDA GUDID since 1 May 2023 (UDI-DI 10192253062991), 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 Number063014000000000000004076N Basic UDI-DI 10192253062991UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10192253062991 UDI-DI Date1 May 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 063014000000000000004076N registered 22 Sep 2026 Active
  • FDA GUDID UDI-DI 10192253062991 listed 1 May 2023 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 10192253062991
  2. Registered EUDAMED 063014000000000000004076N

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  • Withdrawn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
Disposable Lead System, Direct Connect
Model / Ref / Catalog
33114N, Disposable Lead System, Direct Connect
Primary DI / UDI-DI
10192253062991
Basic UDI-DI
063014000000000000004076N
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 registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 4.2 Feet

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 lead set, single-use

Similar devices in this category

Other devices filed under ELECTROSURGERY CONNECTION CABLES, SINGLE-USE.

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
Other properties (21, all answered No)