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EdgeLife Technologies E8200

by Edgelife Technologies, LLC

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 Number00860013043605 UDI-DIDate10 Jul 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  • Withdrawn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
EdgeLife Technologies
Generic Name
Hand-held ultrasound imaging system, body-surface
Model / Reference
E8200
Primary DI / UDI-DI
00860013043605
510(k) Number
FDA Product Code
IYN, IYO, ITX
GMDN Term
Hand-held ultrasound imaging system, body-surface
Device Class
Class II
Regulation Number
892.1550, 892.1560, 892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K234153)

Other devices from Edgelife Technologies, LLC

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

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