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Automated Hematology Analyzer Lyse

by MedicalSystem Biotechnology Co., Ltd. FDA registration: China EUDAMED

Ref XQ9009YModel LYC-1, LYC-2 EMDN W0103010103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number693659579008PP Basic UDI-DIDate13 Oct 2023RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Model / Reference
LYC-1, LYC-2, XQ9009Y
Primary DI / UDI-DI
06970291980906
Basic UDI-DI
693659579008PP
EMDN Code
W0103010103 Complete cell count
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000010246
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Medicalsystem Biotechnology Co., Ltd.

See all devices from Medicalsystem Biotechnology 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 fa854ba7-00ec-4cb4-88a2-293bde5b328f 61 fields · synced 24 Oct 2026