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May-Grünwald

by Cypress Diagnostics

Ref HS004Model HS003 - HS004

May-Grünwald (HS004) is an in vitro diagnostic device (EU IVDR Class A; EMDN category romanowsky stains) made by Cypress Diagnostics, registered in EUDAMED on 17 Nov 2023 (Basic UDI-DI 54040351HS00365), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54040351HS00365 Basic UDI-DI 05404035100134UDI-DIDate17 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  • Withdrawn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
Giemsa - May-Grünwald
Model / reference
HS003 - HS004, HS004
Primary DI / UDI-DI
05404035100134
Basic UDI-DI
54040351HS00365
Direct marketing DI
05404035100134
EMDN code
W0103010302 Romanowsky stains
Device class
Class A
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000033

Similar devices in this category

Other devices filed under ROMANOWSKY STAINS.

Other devices from Cypress Diagnostics

See all devices from Cypress Diagnostics →

Properties

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