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MoiM Dx100

by igenetech Inc.

Ref IGTDX100Model Dx100

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 Number880026557MoiMDx100RH Basic UDI-DI 08800265570032UDI-DIDate20 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  • Withdrawn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

Model / Reference
Dx100, IGTDX100
Primary DI / UDI-DI
08800265570032
Basic UDI-DI
880026557MoiMDx100RH
Direct Marketing DI
08800265570032
EMDN Code
W02050301 Nucleic acid testing apparatuses - rapid and point of care tests
Device Class
Class A
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000060117
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from igenetech Inc.

Properties

  • Near-Patient Testing
  • Professional Testing
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No