Skip to content

Setmark Inc. ST-103

by Setmark Inc.

Setmark Inc. ST-103 is an overbed table (FDA Class I; FDA product code HRK, Table, Instrument, Manual, Ophthalmic) made by Setmark Inc., listed in FDA GUDID since 27 Feb 2026 (UDI-DI 00854204008450), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854204008450 UDI-DI Date27 Feb 2026ListedStatusListed 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  • Withdrawn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
Setmark Inc.
Generic name
Overbed table
Model / reference
ST-103
Primary DI / UDI-DI
00854204008450
FDA product code
HRK
GMDN term
Overbed table
Device class
Class I
Regulation number
886.4855
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Other devices from Setmark Inc.

See all devices from Setmark Inc. →

Properties

  • Premarket exempt
  • Manufacturing date
Other properties (13, all answered No)