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LH Lyse for Hematology Analyzer

by Shenzhen Xilaiheng Medical Electronics Co., Ltd. EUDAMED

Active European Union EUDAMED: not on the EU market

Ref /Model W-61LH

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6975200385RXJHD Basic UDI-DIDate17 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — 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

Device Name
LH Lyse for Hematology Analyzer
Model / Reference
W-61LH, /
Primary DI / UDI-DI
06975200383144
Basic UDI-DI
6975200385RXJHD
Direct Marketing DI
06975200383144
EMDN Code
W01019099 Clinical chemistry reagents - other
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000047090
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Shenzhen Xilaiheng Medical Electronics Co., Ltd.

Properties

  • Reagent

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No