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Lyse for Hematology Analyzer

by Rayto Life and Analytical Sciences Co., Ltd. China EUDAMED

Ref RL-86D,1LModel RL-86D，RL-86H EMDN W0103010105

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69470244033085Y Basic UDI-DIDate21 Apr 2022RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Model / Reference
RL-86D，RL-86H, RL-86D, 1L
Primary DI / UDI-DI
06947024410115
Basic UDI-DI
69470244033085Y
Direct Marketing DI
06947024410115
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Rayto Life and Analytical Sciences Co., Ltd.

See all devices from Rayto Life and Analytical Sciences Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 6395d5f0-6887-425c-ae77-a441633ffa5a 61 fields · synced 25 Oct 2026