Skip to content

Giemsa Kit (2 x 50 mL)

by Quimica Clinica Aplicada S.A.

Ref 994305

Active European Union

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8430155GIEMSARC Basic UDI-DI 18430155009969UDI-DIDate11 Jan 2024RegisteredStatusActive

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  • Withdrawn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 Stain
Model / Reference
994305
Primary DI / UDI-DI
18430155009969
Basic UDI-DI
8430155GIEMSARC
EMDN Code
W0103010302 Romanowsky stains
Device Class
Class A
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000001512

Other devices from Quimica Clinica Aplicada S.A.

See all devices from Quimica Clinica Aplicada S.A. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No