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Hematology Analyzer Diluent

by Guangdong Hao Jiang Laboratories Co., Ltd. EUDAMED

Active European Union

Ref HD1：10LModel HD1：10L、20L，HD2：10L、20L，HD3：5L、10L、20L，HD4：20L，HD5：20L，HD6：20L，D22：20L，52D：5.5L、10L、20L，D86：10L、20L，72D：20L，RD86：20L，SKD：2L、5L、20L，GD5：20L，etc.

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number698035178HADQJ Basic UDI-DIDate5 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  • Withdrawn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 Diluent
Model / Reference
HD1：10L、20L，HD2：10L、20L，HD3：5L、10L、20L，HD4：20L，HD5：20L，HD6：20L，D22：20L，52D：5.5L、10L、20L，D86：10L、20L，72D：20L，RD86：20L，SKD：2L、5L、20L，GD5：20L，etc., HD1：10L
Primary DI / UDI-DI
06980351780001
Basic UDI-DI
698035178HADQJ
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
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