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Guardia G54190

by Cook Incorporated

Ref J-UOB-4028

Guardia G54190 (J-UOB-4028) is an assisted reproduction transfer catheter/set (EU MDD Class I; FDA Class II; FDA product code MQF, Catheter, Assisted Reproduction) made by Cook Incorporated, registered in EUDAMED on 11 Aug 2026 (Basic UDI-DI B-00827002541900) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00827002541900), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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/MDD EUDAMED NumberB-00827002541900 Basic UDI-DI 00827002541900UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002541900 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002541900 registered 11 Aug 2026 Active
  • FDA GUDID UDI-DI 00827002541900 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00827002541900
  2. Registered EUDAMED B-00827002541900

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Guardia™ EUDAMED
Guardia GUDID
Generic name
Assisted reproduction transfer catheter/set
Model / Ref / Catalog
J-UOB-4028, G54190
Primary DI / UDI-DI
00827002541900
Basic UDI-DI
B-00827002541900
FDA product code
MQF
EMDN code
U080299 Devices for assisted reproduction - other
GMDN term
Assisted reproduction transfer catheter/set
Device class
Class I EUDAMED
Class II GUDID
Regulation number
884.6110
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
J-UOB-4028
GUDID
G54190
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: Peritoneal catheter stylet

Similar devices in this category

Other devices filed under DEVICES FOR ASSISTED REPRODUCTION - OTHER.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)