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Fully automatic dynamic erythrocyte sedimentation rate analyzer

by Jiangsu Hongen Medical Devices Co., Ltd. China EUDAMED

Ref HXC-01Model HXC-01、HXC-02、HXC-03、HXC-04、HXC-05、HXC-06 EMDN W02029099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697949734FADESRA0139 Basic UDI-DIDate13 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Fully automatic dynamic erythrocyte sedimentation rate analyzer
Model / Reference
HXC-01、HXC-02、HXC-03、HXC-04、HXC-05、HXC-06, HXC-01
Primary DI / UDI-DI
06979497340019
Basic UDI-DI
697949734FADESRA0139
EMDN Code
W02029099 Various hematology / histology / cytology instruments - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000051431
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jiangsu Hongen Medical Devices Co., Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED 9cfc5206-c2af-4555-8715-1ad7cf5c391e 61 fields · synced 22 Oct 2026