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Kangaroo 386100R

by Cardinal Health 200, LLC

Ref 386100RModel KANGAROO Feeding Tube with IRIS Technology

Kangaroo 386100R 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 9 Oct 2026 (Basic UDI-DI 063014000000000000000796T) and listed in FDA GUDID since 2 Feb 2023 (UDI-DI 50192253016381), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063014000000000000000796T Basic UDI-DI 50192253016381UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number50192253016381 UDI-DI Date2 Feb 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 063014000000000000000796T registered 9 Oct 2026 Active
  • FDA GUDID UDI-DI 50192253016381 listed 2 Feb 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 50192253016381
  2. Registered EUDAMED 063014000000000000000796T

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  • Withdrawn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
Kangaroo
Generic name
Image display unit, colour
Device name
KANGAROO Feeding Tube with IRIS Technology
Model / Ref / Catalog
386100R, KANGAROO Feeding Tube with IRIS Technology
Primary DI / UDI-DI
50192253016381
Basic UDI-DI
063014000000000000000796T
FDA product code
KNT
EMDN code
Z120799 Gastroenterology instruments -other
GMDN term
Image display unit, colour
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.5980
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 · 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: Image display unit, colour

Similar devices in this category

Other devices filed under GASTROENTEROLOGICAL INSTRUMENTS.

Other devices from Cardinal Health 200, LLC

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Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)