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EpiWatch 1

by Epiwatch, Inc.

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 Number00860013047702 UDI-DIDate20 Mar 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  • Withdrawn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
EpiWatch
Generic Name
Clinical decision management support software
Model / Reference
1
Primary DI / UDI-DI
00860013047702
510(k) Number
FDA Product Code
POS
GMDN Term
Clinical decision management support software
Device Class
Class II
Regulation Number
882.1580
GUDID distribution status
In Commercial Distribution

Other devices from Epiwatch, Inc.

Properties

  • Single Use
  • Prescription Use

Other properties (12)

  • Sterile: 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No