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ECGenius System

by CathVision ApS Denmark EUDAMED510(k)GUDID

Ref CVT-0069 R3.2 ECGenius SystemModel CVT-0069 R2.0

Product code DQKEMDN C020199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number57000021685ECGENIUSR2LP Basic UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number15745001034006 UDI-DIDate22 Apr 2024ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK223787 Date4 Aug 2023IssuedStatusActive

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) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 24 Oct 2026

Generic Name
Cardiac electrophysiology analysis system
Model / Ref / Catalog
CVT-0069 R2.0, CVT-0069 R3.2 ECGenius System, CVT-0069 R3.2
Primary DI / UDI-DI
15745001034006 EUDAMED
05745001034009 GUDID
Basic UDI-DI
57000021685ECGENIUSR2LP
Direct Marketing DI
05745001034009
510(k) Number
FDA Product Code
DQK
EMDN Code
C020199 Cardiac electrophysiology and mapping devices - other
GMDN Term
Cardiac electrophysiology analysis system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1425
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
CVT-0069 R2.0
CVT-0069 R3.2 ECGenius System
GUDID
CVT-0069 R3.2
Primary DI / UDI-DIEUDAMED
15745001034006
GUDID
05745001034009
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DK-MF-000008517

Other devices from Cathvision ApS

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • 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
  • Expiration Date: No

Sources (3)

  • EUDAMED 526beba9-9eb9-4844-b812-b820c586963c 61 fields · synced 24 Oct 2026
  • FDA UDI e1124c88-39c5-4b38-984f-f4c384204c5f 35 fields · synced 30 May 2026
  • FDA 510(k) K223787 1 fields · synced 18 May 2026