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Hematology Analyzer Dye

by Guangdong Hao Jiang Laboratories Co., Ltd. EUDAMED

Active European Union

Ref DD5：42mLModel DD5：42mL、42mL×3,4DS：42mL、42mL×3，M68FD：48mL、48mL×4,WNR：82mL、82mL×2，WDF：22mL、22mL×2、42mL、42mL×2，RET：12mL、12mL×2， M60FD：12mL、12mL×4、48mL、48mL×4， M60FN：12mL、12mL×4、48mL、48mL×4，etc

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number698035178HAYRU Basic UDI-DIDate10 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Hematology Analyzer Dye
Model / Reference
DD5：42mL、42mL×3, 4DS：42mL、42mL×3，M68FD：48mL、48mL×4, WNR：82mL、82mL×2，WDF：22mL、22mL×2、42mL、42mL×2，RET：12mL、12mL×2， M60FD：12mL、12mL×4、48mL、48mL×4， M60FN：12mL、12mL×4、48mL、48mL×4，etc, DD5：42mL
Primary DI / UDI-DI
06980351782197
Basic UDI-DI
698035178HAYRU
EMDN Code
W0103010301 Histo / cyto stains
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057458
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Guangdong Hao Jiang Laboratories Co., Ltd.

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