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Techcyte Fusion AP

by Techcyte, Inc.

Ref TEC-01-05Model Techcyte Fusion AP V1.0

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number199874FusionAP0015C Basic UDI-DI 00199874004136UDI-DIDate3 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
Techcyte Fusion AP V1.0, TEC-01-05
Primary DI / UDI-DI
00199874004136
Basic UDI-DI
199874FusionAP0015C
Direct Marketing DI
00199874004136
EMDN Code
W0202050392 Laboratory instruments for microscopic investigations - IVD medical device software
Device Class
Class A
Special Device Type
Software
EU market of registration
Germany

Manufacturer details

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

From the manufacturer

Manufacturer's product page: Techcyte Fusion® Partner Program

Other devices from Techcyte, Inc.

Properties

  • Professional Testing

Other properties (10)

  • 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
  • New Device: No