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AssureCheck™ ST2000

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00686864061267 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  • Withdrawn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 reader
Model / reference
ST2000
Primary DI / UDI-DI
00686864061267
FDA product code
FRC
GMDN term
Biological sterilization indicator reader
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

  • Contains latex
  • Over-the-counter
  • Lot / batch number
  • Manufacturing date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Prescription use: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No