Skip to content

Signos Glucose Management System SOTC1

by Signos, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00860013992606 UDI-DI Date24 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Signos Glucose Management System
Generic Name
Percutaneous interstitial fluid glucose monitoring system, electrochemical
Model / Reference
SOTC1
Primary DI / UDI-DI
00860013992606
510(k) Number
FDA Product Code
SAF
GMDN Term
Percutaneous interstitial fluid glucose monitoring system, electrochemical
Device Class
Class II
Regulation Number
862.1355
GUDID distribution status
In Commercial Distribution

Other devices from Signos, Inc.

Properties

  • Over-the-Counter
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No