Skip to content

Kendall 31481396

by Cardinal Health 200, LLC

Ref 31481396Model KENDALL Fetal Spiral Electrode Attachment Pad

Kendall 31481396 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 11 Sep 2026 (Basic UDI-DI 0630140000000000000010767) and listed in FDA GUDID since 23 Feb 2021 (UDI-DI 10192253021158), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0630140000000000000010767 Basic UDI-DI 10192253021158UDI-DIDate11 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10192253021158 UDI-DI Date23 Feb 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0630140000000000000010767 registered 11 Sep 2026 Active
  • FDA GUDID UDI-DI 10192253021158 listed 23 Feb 2021 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 10192253021158
  2. Registered EUDAMED 0630140000000000000010767

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  • Withdrawn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
Foetal scalp electrode, spiral
Model / Ref / Catalog
31481396, KENDALL Fetal Spiral Electrode Attachment Pad
Primary DI / UDI-DI
10192253021158
Basic UDI-DI
0630140000000000000010767
FDA product code
HGP
EMDN code
C020501 ECG electrodes
GMDN term
Foetal scalp electrode, spiral
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.2675
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Outer Diameter — 1.88 Inch

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: Foetal scalp electrode, spiral

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
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)