Skip to content

FLUFSAN LADY EXTRA for medium incontinence

by Europrosan SpA

Part of a family of 16 devices: see the family page

Ref 701020Model PADS INSERT TYPE, SINGLE USE

FLUFSAN LADY EXTRA for medium incontinence (701020) is a Class I device made by Europrosan SpA, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 8015013FLSARE305096) and listed in FDA GUDID since 31 Jan 2025 (UDI-DI 08015013701020), 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 Number8015013FLSARE305096 Basic UDI-DI 08015013701020UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08015013701020 UDI-DI Date31 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8015013FLSARE305096 registered 23 Jun 2026 Active
  • FDA GUDID UDI-DI 08015013701020 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 08015013701020
  2. Registered EUDAMED 8015013FLSARE305096

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  • Withdrawn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
Adult nappy
Device name
Flufsan Rettangolare
Model / Ref / Catalog
PADS INSERT TYPE, SINGLE USE, 701020, LADY EXTRA for medium incontinence
Description
ABSORBENT PROTECTION FOR LADY 10 PIECES PER BAG
Primary DI / UDI-DI
08015013701020
Basic UDI-DI
8015013FLSARE305096
Direct marketing DI
08015013701020
FDA product code
EYQ
EMDN code
T04010102 Shaped incontinence nappies
GMDN term
Adult nappy
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
PADS INSERT TYPE, SINGLE USE
701020
GUDID
LADY EXTRA for medium incontinence

Related devices

Category: Adult nappy

Similar devices in this category

Other devices filed under INCONTINENCE NAPPIES.

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)