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Flufsan Soft Xlarge Day

by Europrosan SpA

Part of a family of 13 devices: see the family page

Ref 301503Model Briefs, Pads with fastener system, single-use

Flufsan Soft Xlarge Day (301503) is a Class I device made by Europrosan SpA, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI 8015013FLADSO30HY) and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 08015013301503), active as of 23 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8015013FLADSO30HY Basic UDI-DI 08015013301503UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08015013301503 UDI-DI Date31 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8015013FLADSO30HY registered 26 Jun 2026 Active
  • FDA GUDID UDI-DI 08015013301503 listed 31 Jan 2025 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 08015013301503
  2. Registered EUDAMED 8015013FLADSO30HY

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  • Withdrawn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
Flufsan
Generic name
Incontinence pants, single-use
Device name
Flufsan Adult Diaper Soft
Model / Ref / Catalog
Briefs, Pads with fastener system, single-use, 301503, FLUFSAN SOFT XLARGE DAY
Description
ADULT INCONTINENCE PANTS SOFT - SIZE XLARGE DEVICE, INCONTINENCE NON-STERILE 15 PIECES PER BAG
Primary DI / UDI-DI
08015013301503
Basic UDI-DI
8015013FLADSO30HY
Direct marketing DI
08015013301503
FDA product code
EYQ
EMDN code
T04010103 Incontinence nappies with integrated fixing system
GMDN term
Incontinence pants, single-use
Device class
Class I
Regulation number
876.5920
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Briefs, Pads with fastener system, single-use
301503
GUDID
FLUFSAN SOFT XLARGE DAY

Related devices

Category: Incontinence pants, single-use

Similar devices in this category

Other devices filed under INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM.

Other devices from Europrosan SpA

See all devices from Europrosan SpA →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)