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Apk I-A511E-EL1

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06946725572115 UDI-DI Date13 Oct 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  • Withdrawn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 lead set, reusable
Model / Reference
I-A511E-EL1
Primary DI / UDI-DI
06946725572115
FDA Product Code
IKD
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class II
Regulation Number
890.1175
GUDID distribution status
In Commercial Distribution

Other devices from Apk Technology

See all devices from Apk Technology →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No