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DIH-500 Portable Hematology and Immunology Analyzer

by Chengdu DynoDx Medical Technologies Co., Ltd. 5 variants

Ref /Model DIH-500P、DIH-500C、DIH-500T、DIH-500E

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697696360DIH-500-EUJN Basic UDI-DI 06976963609106UDI-DIDate12 Oct 2026RegisteredStatusActive

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  • Withdrawn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
DIH-500 Portable Hematology and Immunology Analyzer
Model / Reference
DIH-500P、DIH-500C、DIH-500T、DIH-500E, /
Primary DI / UDI-DI
06976963609106
Basic UDI-DI
697696360DIH-500-EUJN
Direct Marketing DI
06976963609106
EMDN Code
W02010199 Chemistry instruments - other
Device Class
Class A
EU market of registration
Spain

Manufacturer details

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

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Properties

  • Professional Testing
  • Surgical Instrument
  • New Device

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