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Wayne G56532

by Cook Incorporated

Ref C-UTPT-1020-WAYNE-IMH

Wayne G56532 (C-UTPT-1020-WAYNE-IMH) is a device classified as Class IIa in the EU and Class II in the US made by Cook Incorporated, registered in EUDAMED on 31 Aug 2026 (Basic UDI-DI B-00827002CINC18YG) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI D-00827002CINC18YG), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002CINC18YG Basic UDI-DI D-00827002CINC18YGUDI-DIDate31 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-00827002CINC18YG UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002CINC18YG registered 31 Aug 2026 Active
  • FDA GUDID UDI-DI D-00827002CINC18YG listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D-00827002CINC18YG
  2. Registered EUDAMED B-00827002CINC18YG

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  • Withdrawn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
Wayne
Generic name
Pleural catheter
Model / Ref / Catalog
C-UTPT-1020-WAYNE-IMH, G56532
Primary DI / UDI-DI
D-00827002CINC18YG EUDAMED
00827002565326 GUDID
Basic UDI-DI
B-00827002CINC18YG
FDA product code
JOL
EMDN code
A060203 Pleural drainages with valve and kits
GMDN term
Pleural catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6740
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
C-UTPT-1020-WAYNE-IMH
GUDID
G56532
Primary DI / UDI-DIEUDAMED
D-00827002CINC18YG
GUDID
00827002565326
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-00827002CINC18YG; FDA GUDID lists 00827002565326), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa 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: Pleural catheter

Similar devices in this category

Other devices filed under PERCUTANEOUS DRAINAGE SYSTEMS.

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)