Skip to content

Complete Blood Count (CBC) Kit

by Chengdu DynoDx Medical Technologies Co., Ltd. EUDAMED

Active European Union

Ref Hematology Instrument Kit, 5 tests/boxModel CBCR type, CBC type

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976963608819 Basic UDI-DIDate9 Oct 2026RegisteredStatusActive

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  • Withdrawn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
Complete Blood Count (CBC) Kit
Model / Reference
CBCR type, CBC type, Hematology Instrument Kit, 5 tests/box
Primary DI / UDI-DI
06976963608819
Basic UDI-DI
B-06976963608819
EMDN Code
W0103010103 Complete cell count
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000059703
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Chengdu DynoDx Medical Technologies Co., Ltd.

See all devices from Chengdu DynoDx Medical Technologies Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

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