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Lugol PVP

by Cypress Diagnostics

Ref HS022Model HS001 - HS014 - HS021 - HS022

Lugol PVP (HS022) is an in vitro diagnostic device (EU IVDR Class A; EMDN category stains) made by Cypress Diagnostics, registered in EUDAMED on 16 Nov 2023 (Basic UDI-DI 54040351HS0015Z), active as of 22 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54040351HS0015Z Basic UDI-DI 05404035100158UDI-DIDate16 Nov 2023RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device name
Gram PVP - Safranin - Carbol Gentian Violet - Lugol Stabilized with PVP
Model / reference
HS001 - HS014 - HS021 - HS022, HS022
Primary DI / UDI-DI
05404035100158
Basic UDI-DI
54040351HS0015Z
Direct marketing DI
05404035100158
EMDN code
W0104010804 Stains
Device class
Class A
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000033

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Properties

  • Reagent
  • IVD kit
  • Professional testing
Other properties (10, all answered No)