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AssureCheck™ ST1020

by Terragene S.A.

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 Number10686864061257 UDI-DI Date16 Oct 2025ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
AssureCheck™
Generic name
Biological sterilization indicator
Model / reference
ST1020
Primary DI / UDI-DI
10686864061257
FDA product code
FRC
GMDN term
Biological sterilization indicator
Device class
Class II
Regulation number
880.2800
GUDID distribution status
In Commercial Distribution

Other devices from Terragene S.A.

See all devices from Terragene S.A. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before 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
  • Manufacturing date: No