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OBIX_INM3-Bio

by Huntleigh Healthcare, Ltd. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05051968048363 UDI-DIDate10 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Obix
Generic Name
Foetal/maternal prenatal monitor
Model / Ref / Catalog
OBIX_INM3-BIO
Primary DI / UDI-DI
05051968048363
510(k) Number
FDA Product Code
HGM
GMDN Term
Foetal/maternal prenatal monitor
Device Class
Class II
Regulation Number
884.2740
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250777)

Show all (12)

Other devices from Huntleigh Healthcare, Ltd.

See all devices from Huntleigh Healthcare, Ltd. →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

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