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Fully Auto 3-Part Hematology Analyzer

by Shenzhen Sinseng Medical Technology Co., Ltd EUDAMED

Active European Union

Ref HAS310

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975569870040 Basic UDI-DIDate20 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD 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
Fully Auto 3-Part Hematology Analyzer
Model / Reference
HAS310
Primary DI / UDI-DI
06975569870040
Basic UDI-DI
B-06975569870040
EMDN Code
W0103010199 Reagents for (automated) haematology analyzer - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

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

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Properties

  • Professional Testing
  • Surgical Instrument

Other properties (8)

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