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Santamedical SM-1100P

by Gurin Products LLC

Santamedical SM-1100P is a pulse oximeter (FDA Class II; FDA product code OCH, Oximeter, Infrared, Sporting, Aviation) made by Gurin Products LLC, listed in FDA GUDID since 29 Jun 2018 (UDI-DI 00858759005513), 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 Number00858759005513 UDI-DI Date29 Jun 2018ListedStatusListed 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  • Withdrawn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
Santamedical
Generic name
Pulse oximeter
Model / reference
SM-1100P
Primary DI / UDI-DI
00858759005513
FDA product code
OCH
GMDN term
Pulse oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter

Similar devices in this category

Other devices filed under Pulse oximeter.

Other devices from Gurin Products LLC

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Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)