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ECG Cables

by APK Technology Co., Ltd. 97 variants

Ref A3029-EK2DBS

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69467255A-ECG-cableA6 Basic UDI-DI 06946725511459UDI-DIDate17 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06946725511459 UDI-DI Date5 Nov 2025ListedStatusListed 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  • Withdrawn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

Trade Name
ECG Cables EUDAMED
Apk GUDID
Generic Name
Electrocardiographic lead set, reusable
Device Name
ECG Lead wires
Model / Reference
A3029-EK2DBS
Primary DI / UDI-DI
06946725511459
Basic UDI-DI
69467255A-ECG-cableA6
FDA Product Code
IKD
EMDN Code
Z12030285 Vital signs monitoring instruments - consumables
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
890.1175
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000011581
Authorised representative
Ruiyi Healthcare GmbH DE-AR-000005962

Other devices from APK Technology Co., Ltd.

See all devices from APK Technology Co., Ltd. →

Properties

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