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Aerospray Hematology Stat Reagent D Aerofix Fixative Concentrate

by ELITechGroup Inc.

Ref SS-148-EUModel Aerospray Stains

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number3661540Aerospray-StainXL Basic UDI-DI 03661540303845UDI-DIDate5 May 2025RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Aerospray Stains, SS-148-EU
Primary DI / UDI-DI
03661540303845
Basic UDI-DI
3661540Aerospray-StainXL
Direct Marketing DI
03661540303845
EMDN Code
W0103010302 Romanowsky stains
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000006942
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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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