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ECG Cable

by Edan Instruments, Inc. 131 variants

Ref DECG-T

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69444138ECGCableOWG Basic UDI-DI 06944413805675UDI-DIDate20 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413805675 UDI-DI Date1 Sep 2016ListedStatusListed 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

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  • Withdrawn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 GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Foetal Doppler system probe
Model / Reference
DECG-T EUDAMED
3MHz GUDID
Primary DI / UDI-DI
06944413805675
Basic UDI-DI
69444138ECGCableOWG
510(k) Number
FDA Product Code
KNG
EMDN Code
Z12030280 Vital signs monitoring instruments - hardware accessories
GMDN Term
Foetal Doppler system probe
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
884.2660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DECG-T
GUDID
3MHz
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

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (22)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No