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FOXSEAL Vented FG08814541

by Medtrade Products, Ltd.

Ref FG08814541

FOXSEAL Vented FG08814541 is a device classified as Class IIb in the EU and Class I in the US made by Medtrade Products, Ltd., registered in EUDAMED on 17 Sep 2026 (Basic UDI-DI B-15060206630694) and listed in FDA GUDID since 4 Feb 2022 (UDI-DI 15060206630694), withdrawn as of 24 Oct 2026.

Withdrawn Withdrawn in European Union.

Was authorized under CE MDD, withdrawn

Ended

Withdrawn

Date not published (CE MDD)

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-15060206630694 Basic UDI-DI 15060206630694UDI-DIDate17 Sep 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number15060206630694 UDI-DI Date4 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-15060206630694 registered 17 Sep 2026 Withdrawn
  • FDA GUDID UDI-DI 15060206630694 listed 4 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 15060206630694
  2. Registered EUDAMED B-15060206630694

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
FOXSEAL Vented
Generic name
Pneumothorax dressing
Device name
Pneumothorax Dressing
Model / Ref / Catalog
FG08814541
Primary DI / UDI-DI
15060206630694
Basic UDI-DI
B-15060206630694
FDA product code
NAD
EMDN code
M04040501 Hydrogel dressings, non-combined
GMDN term
Pneumothorax dressing
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
878.4020
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Pneumothorax dressing

Similar devices in this category

Other devices filed under HYDROGEL DRESSINGS, NON-COMBINED.

Other devices from Medtrade Products, Ltd.

See all devices from Medtrade Products, Ltd. →

Properties

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