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Fogarty 410236F

by Edwards Lifesciences LLC

Ref 410236F

Fogarty 410236F is a device classified as Class IIa in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 0690103D001FBB000LM) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00690103219838), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001FBB000LM Basic UDI-DI 00690103219838UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00690103219838 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001FBB000LM registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 00690103219838 listed 3 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00690103219838
  2. Registered EUDAMED 0690103D001FBB000LM

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  • Withdrawn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
Fogarty
Generic name
Biliary drain
Device name
Fogarty Biliary Balloon Probe
Model / Ref / Catalog
410236F
Primary DI / UDI-DI
00690103219838 EUDAMED
00690103043655 GUDID
Basic UDI-DI
0690103D001FBB000LM
FDA product code
GCA
EMDN code
G0301010401 Biliary balloon catheters, low pressure
GMDN term
Biliary drain
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5010
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00690103219838
GUDID
00690103043655
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00690103219838; FDA GUDID lists 00690103043655), 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: Biliary drain

Similar devices in this category

Other devices filed under BILIARY BALLOON CATHETERS.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

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