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Wello, Inc welloStationX

by Wello, 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 Number00860011348603 UDI-DI Date25 Jul 2024ListedStatusListed 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  • Withdrawn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
Wello, Inc
Generic Name
Body temperature screening thermometer station
Model / Reference
welloStationX
Primary DI / UDI-DI
00860011348603
510(k) Number
FDA Product Code
FLL
GMDN Term
Body temperature screening thermometer station
Device Class
Class II
Regulation Number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Body temperature screening thermometer station

Other devices from Wello, Inc.

  • welloStationX

    Class II

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No