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Apk A00001D03-001

by APK Technology Co., Ltd.

Part of a family of 79 devices: see the family page

Ref A0001D03-001

Apk A00001D03-001 is a device classified as Class I in the EU and Class II in the US made by APK Technology Co., Ltd., registered in EUDAMED on 17 Nov 2025 (Basic UDI-DI 69467255A-DECG-cableZF), cleared under FDA 510(k) K170536 on 24 Apr 2017 and listed in FDA GUDID since 6 Jul 2018 (UDI-DI 06946725527023), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K170536

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69467255A-DECG-cableZF Basic UDI-DI 06946725527023UDI-DIDate17 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06946725527023 UDI-DI Date6 Jul 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170536 Date24 Apr 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 69467255A-DECG-cableZF registered 17 Nov 2025 Active
  • FDA 510(k) K170536 decided 24 Apr 2017 Active
  • FDA GUDID UDI-DI 06946725527023 listed 6 Jul 2018 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K170536
  2. Listed FDA GUDID 06946725527023
  3. Registered EUDAMED 69467255A-DECG-cableZF

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ECG Disposable Lead wires EUDAMED
Apk GUDID
Generic name
Electrocardiographic lead set, single-use
Device name
Disposable ECG Lead wires
Model / reference
A0001D03-001 EUDAMED
A00001D03-001 GUDID
Primary DI / UDI-DI
06946725527023
Basic UDI-DI
69467255A-DECG-cableZF
510(k) Number
FDA product code
DSA
EMDN code
Z12030285 Vital signs monitoring instruments - consumables
GMDN term
Electrocardiographic lead set, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2900
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
A0001D03-001
GUDID
A00001D03-001
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrocardiographic lead set, single-use

Cleared under the same submission (K170536)

and 8 more cleared under K170536

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS.

Other devices from APK Technology Co., Ltd.

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

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)