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Hematology Analyzer Lyse

by Biobase Biodustry(Shandong) Co., Ltd. EUDAMED

Active European Union

Ref WFL-LD 500mL（15103）

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number69368953HAL132R5 Basic UDI-DIDate7 Jul 2026RegisteredStatusActive
European UnionCE/IVDR Number69368953HAL132R5 Basic UDI-DIDate7 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
WFL-LD 500mL（15103）
Primary DI / UDI-DI
06936895303916
Basic UDI-DI
69368953HAL132R5, B-06936895303916
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025015
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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Properties

  • 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