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Techcyte Blood Differential Algorithm

by Techcyte, Inc.

Ref TEC-01-03

Active European Union

CE IVDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00199874953724 Basic UDI-DI 00199874953724UDI-DIDate17 Sep 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
TEC-01-03
Primary DI / UDI-DI
00199874953724
Basic UDI-DI
B-00199874953724
EMDN Code
W02029092 Various hematology / histology / cytology instruments - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000047150
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Techcyte, Inc.

Properties

  • Professional Testing

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
  • Surgical Instrument: No