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Diluent, Lyse and Cleaner used for Hematology Analysis

by Shenzhen Sinseng Medical Technology Co., Ltd

Ref SXHA610 DIFF LyseModel SXHA610/650/660/680 Diluent; HAS310/330/360/380 Diluent; SXHA610/650/660/680 DIFF Lyse; SXHA610/650/660/680 LH Lyse; HAS310/330/360/380 Lyse; Cleaner

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697556987DLCYN Basic UDI-DI 06975569870071UDI-DIDate17 Dec 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Diluent, Lyse and Cleaner used for Hematology Analysis
Model / Reference
SXHA610/650/660/680 Diluent, HAS310/330/360/380 Diluent, SXHA610/650/660/680 DIFF Lyse, SXHA610/650/660/680 LH Lyse, HAS310/330/360/380 Lyse, Cleaner, SXHA610 DIFF Lyse
Primary DI / UDI-DI
06975569870071
Basic UDI-DI
697556987DLCYN
EMDN Code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000024231
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Shenzhen Sinseng Medical Technology Co., Ltd

Properties

  • Reagent
  • Professional Testing
  • New Device

Other properties (8)

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