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Kendall 33544

by Cardinal Health 200, LLC

Ref 33544-Model Adapter, 6 lead, SpO2 Compatible

Kendall 33544 (33544-) 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 14 Sep 2026 (Basic UDI-DI 0630140000000000000037674) and listed in FDA GUDID since 3 Jan 2023 (UDI-DI 10192253019889), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0630140000000000000037674 Basic UDI-DI 10192253019889UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10192253019889 UDI-DI Date3 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0630140000000000000037674 registered 14 Sep 2026 Active
  • FDA GUDID UDI-DI 10192253019889 listed 3 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10192253019889
  2. Registered EUDAMED 0630140000000000000037674

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  • Withdrawn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, reusable
Device name
Adapter, 6 lead, SpO2 Compatible
Model / Ref / Catalog
Adapter, 6 lead, SpO2 Compatible, 33544-, 33544
Primary DI / UDI-DI
10192253019889
Basic UDI-DI
0630140000000000000037674
FDA product code
IKD
EMDN code
K02010203 Electrosurgery connection cables, single-use
GMDN term
Electrocardiographic lead set, reusable
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

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Adapter, 6 lead, SpO2 Compatible
33544-
GUDID
33544
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, reusable

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

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)