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Advance G30927

by Cook Incorporated

Ref PTA4-18-80-10-2

Advance G30927 (PTA4-18-80-10-2) is a device classified as Class IIa in the EU and Class II in the US made by Cook Incorporated, registered in EUDAMED on 10 Apr 2026 (Basic UDI-DI B-00827002309272) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00827002309272), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00827002309272 Basic UDI-DI 00827002309272UDI-DIDate10 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002309272 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00827002309272 registered 10 Apr 2026 Active
  • FDA GUDID UDI-DI 00827002309272 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00827002309272
  2. Registered EUDAMED B-00827002309272

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  • Withdrawn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
Advance® 18LP EUDAMED
Advance GUDID
Generic name
Peripheral angioplasty balloon catheter, basic
Device name
Advance® 18LP Low Profile PTA Ballon Dilatation Catheter
Model / Ref / Catalog
PTA4-18-80-10-2, G30927
Primary DI / UDI-DI
00827002309272 EUDAMED
10827002309279 GUDID
Basic UDI-DI
B-00827002309272
FDA product code
LIT
EMDN code
C010402020101 PTA balloon dilatation catheters
GMDN term
Peripheral angioplasty balloon catheter, basic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1250
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
PTA4-18-80-10-2
GUDID
G30927
Primary DI / UDI-DIEUDAMED
00827002309272
GUDID
10827002309279
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00827002309272; FDA GUDID lists 10827002309279), 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: Peripheral angioplasty balloon catheter, basic

Similar devices in this category

Other devices filed under PTA BALLOON DILATATION CATHETERS.

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)