Consulting Wallah › Device Explorer › Other devices › Pulse oximeter probe, single-use
Device Explorer · FDA GUDID · GMDN 31658

Pulse oximeter probe, single-use

A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced

US‑registered devices1,640in commercial distribution
Companies30labelers on GUDID
Single‑use97%of device records
Sterile3%labelled sterile
Prescription28%Rx‑only share
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Share of device records

Apk Technology Co.,Ltd.67241%
Unimed Medical Supplies, Inc.51231%
Masimo Corporation1509%
Covidien Lp493%
Curbell Medical Products, Inc.362%
Shenzhen Med-Link Electronics Tech Co.,Ltd.332%
Osi Optoelectronics, Inc.241%
Sensoronics Incorporated211%

Top labelers

CompanyDevicesShare
Apk Technology Co.,Ltd.67241%
Unimed Medical Supplies, Inc.51231%
Masimo Corporation1509%
Covidien Lp493%
Curbell Medical Products, Inc.362%
Shenzhen Med-Link Electronics Tech Co.,Ltd.332%
Osi Optoelectronics, Inc.241%
Sensoronics Incorporated211%
Nonin Medical, Inc.201%
Nihon Kohden Corporation151%
Healthcare Logistics Systems Llc151%
Shenzhen Sino-K Medical Technology Co.,Ltd111%

Company = labeler of record on GUDID. 30 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SINO-KMedkeAPKNihon Kohden DisposableUnimedUNimedMED-LINKSAGEMed-linkSageOrantechDisposable SpO2 SensorsCaremedBluPRO®SpO2 Draeger Ped Foam, 24 pcs.SpO2 Draeger Adult Foam, 24 pcs.

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DQAOximeter1,661
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR22
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQU22
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)15
GWQFull-montage Standard Electroencephalograph15
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio6

GMDN & GCC registration

  • GMDN code 31658 · non‑implantable
  • Single‑use 97% · sterile 3% · Rx‑only 28% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 34Length (Millimeter) · 34Height (Millimeter) · 32Depth (Millimeter) · 2

Use these as the dimensions to specify in a tender line.

How many pulse oximeter probe, single-use products are registered in the US?

1,640 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulse oximeter probe, single-use", from 30 companies. The largest labeler is Apk Technology Co.,Ltd. with 41% of records.

Which FDA product codes apply?

DQA (Oximeter), MHX (MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR), DRG (TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQU), DRT (MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM))

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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