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FEops HEARTguide

by FEops NV Belgium EUDAMED510(k)GUDID

Ref 05430002070131Model FEops HEARTguide Simulation Application510(k) DEN200030

Product code QQIEMDN Z11039092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK250635 Date25 Nov 2025IssuedStatusActive
United StatesGUDID listing GUDID Number05430002070131 UDI-DIDate24 Sep 2025ListedStatusListed
European UnionCE/MDR EUDAMED Number5430002070FHG-SAEH Basic UDI-DIDate2 Nov 2021RegisteredStatusActive
United StatesFDA De Novo 510(k) NumberDEN200030 Date8 Sep 2021IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k), FDA De Novo Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Trade Name
FEops HEARTguide EUDAMED
FEops GUDID
Generic Name
Radiology DICOM image processing application software
Model / Ref / Catalog
FEops HEARTguide Simulation Application, 05430002070131, 4.1.0
Primary DI / UDI-DI
05430002070131
Basic UDI-DI
5430002070FHG-SAEH
FDA Product Code
QQI
EMDN Code
Z11039092 Various radiodiagnostic and interventional instruments - medical device software
GMDN Term
Radiology DICOM image processing application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1405
Special Device Type
Software
Market of Registration
Belgium
Commercial Distribution
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
FEops HEARTguide Simulation Application
05430002070131
GUDID
4.1.0
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
BE-MF-000001008

Other devices from FEops NV

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED 5630e961-c95b-4838-8563-62df1cd5240f 85 fields · synced 22 Oct 2026
  • FDA UDI 7feea920-9456-4a16-9d8c-f41df5572fea 35 fields · synced 22 Oct 2026
  • FDA 510(k) K214066 1 fields · synced 18 May 2026