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HepaFatSmart

by Resonance Health Analysis Services

Ref Version 2.0.0510(k) K231459

Active European Union and United States

CE MDR 510(k)

Valid until

21 Aug 2030

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

510(k) K231459↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000316512 Date13 May 2026IssuedStatusActive expires 21 Aug 2030
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK231459 Date20 Jun 2023ClearedStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000316512 Active Supplemented

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    13 May 2026
    Expires
    21 Aug 2030
    Reason
    Change approved

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Device Name
Standalone Software (Software as Medical Devices)
Model / Reference
Version 2.0.0
Primary DI / UDI-DI
93555290000952
Basic UDI-DI
93555290SMD4Z, 93555290HFS3K
Direct Marketing DI
93555290000952
510(k) Number
FDA Product Code
LNH
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 892.1000
Special Device Type
Software
EU market of registration
Germany
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Manufacturer details

EUDAMED SRN
AU-MF-000026337
FDA applicant
Resonance Health Analysis Services Pty, Ltd.
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Resonance Health Analysis Services

See all devices from Resonance Health Analysis Services →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No