Skip to content

INCYTO C-Chip

by INCYTO Co., Ltd. 8 variants

Ref DHC-N01-5Model Disposable Hemocytometer (INCYTO C-Chip)

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 Number88000239CHIPLF Basic UDI-DI 08800023900026UDI-DIDate16 Dec 2024RegisteredStatusActive

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  • Withdrawn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
Disposable Hemocytometer (INCYTO C-Chip)
Model / Reference
Disposable Hemocytometer (INCYTO C-Chip), DHC-N01-5
Primary DI / UDI-DI
08800023900026
Basic UDI-DI
88000239CHIPLF
EMDN Code
W0599 IVD general use consumable devices - other
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000011868
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from INCYTO Co., Ltd.

See all devices from INCYTO Co., Ltd. →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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