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MR High Impedance ECG Cable

by GE Medical Systems LLC 2 variants

Ref 5801659-3 (E8819HY)Model MR High Impedance ECG Cable

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00153H6 Basic UDI-DI 00840682146395UDI-DIDate15 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682146395 UDI-DI Date20 Sep 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
MRI system synchronizer
Model / Reference
MR High Impedance ECG Cable EUDAMED
5801659-3 (E8819HY) EUDAMED
5801659-3 GUDID
Primary DI / UDI-DI
00840682146395
Basic UDI-DI
8406821BUG00153H6
FDA Product Code
IXO
EMDN Code
Z1105018099 Magnetic resonance (MR) systems - hardware accessories - other
GMDN Term
MRI system synchronizer
Device Class
Class I
Regulation Number
892.1970
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MR High Impedance ECG Cable
5801659-3 (E8819HY)
GUDID
5801659-3

Manufacturer details

EUDAMED SRN
US-MF-000001632
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from GE Medical Systems, LLC

See all devices from GE Medical Systems, LLC →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No