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Hq-6D Hematology Controls

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref /Model HQ-6D EMDN W0103010501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-2-1397 Basic UDI-DIDate25 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
HQ-6D, /
Primary DI / UDI-DI
D-2-1397
Basic UDI-DI
B-2-1397
EMDN Code
W0103010501 Normal blood controls
Device Class
Class IVD General
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000011840
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from URIT Medical Electronic Co., Ltd.

See all devices from URIT Medical Electronic Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED D-2-1397|B-2-1397 61 fields · synced 25 Oct 2026