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Hematology Analyzer LYSE

by Shenzhen CoooSeee Biomedical Co., Ltd. 33 variants

Ref 6600-PA00043Model 3LHD, 5LDA, 5LDB, 5LH, 5LDS, 5LHS, 6LD, 6LH, 6LN

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697806677SE001NN Basic UDI-DI 06978066773524UDI-DIDate3 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
3LHD, 5LDA, 5LDB, 5LH, 5LDS, 5LHS, 6LD, 6LH, 6LN, 6600-PA00043
Primary DI / UDI-DI
06978066773524
Basic UDI-DI
697806677SE001NN
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000045646
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

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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