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ECG Cable

by Edan Instruments, Inc. 131 variants

Ref EL05DASY1

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

Recall on shared 510(k) K161056; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69444138ECGCablePWJ Basic UDI-DI 06944413803725UDI-DIDate20 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413803725 UDI-DI Date23 Feb 2017ListedStatusListed 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.

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1155-2026 FDA Class II initiated 24 Oct 2025 on shared 510(k) K161056

    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

    • Terminated Z-1256-2020 FDA Class II initiated 17 Nov 2017 on shared 510(k) K161056

    Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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

Trade Name
ECG Cable EUDAMED
iT20 ECG cable GUDID
Generic Name
Electrocardiographic lead set, reusable
Model / Reference
EL05DASY1 EUDAMED
5-lead GUDID
snap GUDID
AHA GUDID
reusable GUDID
Primary DI / UDI-DI
06944413803725
Basic UDI-DI
69444138ECGCablePWJ
510(k) Number
FDA Product Code
DSA
EMDN Code
Z12030280 Vital signs monitoring instruments - hardware accessories
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2900
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
EL05DASY1
GUDID
5-lead, snap,AHA, reusable
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000009957
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Electrical-only medical device connection cable, reusable

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial 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
  • Premarket Exempt: No
  • Expiration Date: No