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Apk A-De-14

by Apk Technology

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06946725504017 UDI-DI Date14 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Apk
Generic name
Electrocardiographic electrode, single-use
Model / reference
A-DE-14
Description
Disposable ECG Electrode,Teardrop,Non-woven φ30*30
Primary DI / UDI-DI
06946725504017
FDA product code
DRX
GMDN term
Electrocardiographic electrode, single-use
Device class
Class II
Regulation number
870.2360
GUDID distribution status
In Commercial Distribution

Other devices from Apk Technology

See all devices from Apk Technology →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (10)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No