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LeucoScreen Plus

by FertiPro

Ref LEUCO_PLUS

LeucoScreen Plus (LEUCO_PLUS) is a device classified as Class B in the EU and Class I in the US made by FertiPro, registered in EUDAMED on 25 May 2023 (Basic UDI-DI 5411967LEUCOP1ZP) and listed in FDA GUDID since 12 Feb 2019 (UDI-DI 05411967003020), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE IVDR

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/IVDR EUDAMED Number5411967LEUCOP1ZP Basic UDI-DI 05411967003020UDI-DIDate25 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number05411967003020 UDI-DI Date12 Feb 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5411967LEUCOP1ZP registered 25 May 2023 Active
  • FDA GUDID UDI-DI 05411967003020 listed 12 Feb 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05411967003020
  2. Registered EUDAMED 5411967LEUCOP1ZP

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Myeloperoxidase (MPO) IVD, kit, enzyme immunohistochemistry
Model / reference
LEUCO_PLUS
Primary DI / UDI-DI
05411967003020
Basic UDI-DI
5411967LEUCOP1ZP
Direct marketing DI
05411967003020
FDA product code
LED
EMDN code
W01030702 Cytochemical staining reagents
GMDN term
Myeloperoxidase (MPO) IVD, kit, enzyme immunohistochemistry
Device class
Class B EUDAMED
Class I GUDID
Regulation number
864.1850
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class B
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
BE-MF-000000313

Similar devices in this category

Other devices filed under HISTOLOGY/CYTOLOGY REAGENTS.

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Properties

  • IVD kit
  • Professional testing
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)