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iDNA Cardio Health

by iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ

Ref Ref.005

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-52004235002160 Basic UDI-DI 52004235002160UDI-DIDate16 Apr 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  • Withdrawn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
Ref.005
Primary DI / UDI-DI
52004235002160
Basic UDI-DI
B-52004235002160
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
GR-MF-000033624

Other devices from iDNA LABORATORIES ΙΔΙΩΤΙΚΟ ΔΙΑΓΝΩΣΤΙΚΟ ΕΡΓΑΣΤΗΡΙΟ ΑΝΩΝΥΜΗ ΕΤΑΙΡΕΙΑ

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