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MX3 Hydration Testing System LAB PRO HYPRO18

by MX3 Diagnostics, Inc.

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 Number00860016483507 UDI-DI Date30 Sep 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
MX3 Hydration Testing System
Generic Name
Tear osmolarity meter
Model / Reference
LAB PRO HYPRO18
Primary DI / UDI-DI
00860016483507
FDA Product Code
JJM
GMDN Term
Tear osmolarity meter
Device Class
Class I
Regulation Number
862.2730
GUDID distribution status
In Commercial Distribution

Properties

  • Premarket Exempt
  • Serial Number

Other properties (12)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No