Skip to content

Apk A5157-EL1-002

by Apk Technology

Ref A5157-EL1-002

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

CE MDR

Valid until

No date given

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69467255A-ECG-cableA6 Basic UDI-DI 06946725504444UDI-DIDate17 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06946725504444 UDI-DI Date4 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  • Withdrawn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
A5157-EL1-002
Primary DI / UDI-DI
06946725504444
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 registration type
Standard device
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

Other devices from Apk Technology

See all devices from Apk Technology →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Expiration date
  • Manufacturing date

Other properties (20)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No