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Hematology Analyzer Lyse

by Shenzhen Dymind Biotechnology Co., Ltd. 96 variants

Ref 12.01.1917AModel D-80LD:500mL，1L，2L，4L；D-80LH:200mL，500mL，1L，2L，4L； D-80LN:500mL，1L，2L，4L；D-80LW:200mL，500mL，1L，2L，4L

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 Number697049309W010300000029S Basic UDI-DIDate26 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
D-80LD:500mL，1L，2L，4L；D-80LH:200mL，500mL，1L，2L，4L； D-80LN:500mL，1L，2L，4L；D-80LW:200mL，500mL，1L，2L，4L, 12.01.1917A
Primary DI / UDI-DI
06976117452091
Basic UDI-DI
697049309W010300000029S
Direct Marketing DI
06976117452091
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000024842
Authorised representative
Eunitor GmbH DE-AR-000005081

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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