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Automated Hematology Analyzer Lyse

by MedicalSystem Biotechnology Co., Ltd. 8 variants

Ref XQ9007YModel LYE-1

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number693659579007PM Basic UDI-DI 06970291980869UDI-DIDate13 Oct 2023RegisteredStatusActive

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  • Withdrawn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
LYE-1, XQ9007Y
Primary DI / UDI-DI
06970291980869
Basic UDI-DI
693659579007PM
EMDN Code
W0103010103 Complete cell count
Device Class
Class A
EU 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

  • 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