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BH-6580 5-Part-Diff Auto Hematology Analyzer

by URIT Medical Electronic Co., Ltd. China EUDAMED

Ref /Model BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100

EMDN W0202010103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69357407IBH000004ND Basic UDI-DIDate9 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
5-Part-Diff Auto Hematology Analyzer
Model / Reference
BH-6180、BH-6580、BH-6680、BH-6600、BH-6500、BH-6100, /
Primary DI / UDI-DI
06935740735278
Basic UDI-DI
69357407IBH000004ND
Direct Marketing DI
06935740735278
EMDN Code
W0202010103 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - HIGH ROUTINE (Throughput > 120 samples/hr)
Device Class
Class B
Market of Registration
Germany

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
  • 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 c97e4018-0f60-4edb-8e35-27a71ff53f97 61 fields · synced 22 Oct 2026