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Device Explorer · FDA GUDID · GMDN 37808

Pulse oximeter probe, reusable

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 devices4,454in commercial distribution
Companies64labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription9%Rx‑only share
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Share of device records

Unimed Medical Supplies, Inc.2,32652%
Apk Technology Co.,Ltd.1,50234%
Orantech Inc.982%
Masimo Corporation661%
Shenzhen Med-Link Electronics Tech Co.,Ltd.631%
Shenzhen Caremed Medical Technology Co., Ltd.451%
Nonin Medical, Inc.421%
Curbell Medical Products, Inc.331%

Top labelers

CompanyDevicesShare
Unimed Medical Supplies, Inc.2,32652%
Apk Technology Co.,Ltd.1,50234%
Orantech Inc.982%
Masimo Corporation661%
Shenzhen Med-Link Electronics Tech Co.,Ltd.631%
Shenzhen Caremed Medical Technology Co., Ltd.451%
Nonin Medical, Inc.421%
Curbell Medical Products, Inc.331%
Sensoronics Incorporated321%
Shenzhen Medke Technology Co., Ltd251%
Edan Instruments, Inc.210%
Philips Medizin Systeme Böblingen Gmbh130%

Company = labeler of record on GUDID. 64 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SCHILLERFingertip Pulse OximeterMedkeCaremedUpnMedAPKUnimedHU810-91nimedUnmiedSPO2 Module (Mindray/Package/ accessory)Disposable SpO2 SensorMasimo Cable accessory kit(8 pin,Adu)Single-Patient Finger SpO2sensor PackageMED-LINKPACIFIC MEDICAL

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

FDA product codes

CodeNameDevices
DQAOximeter4,515
OCHOximeter, Infrared, Sporting, Aviation17
DPZOximeter, ear16
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR14
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection O9
MWIMonitor, Physiological, Patient (Without Arrhythmia Detectio9

GMDN & GCC registration

  • GMDN code 37808 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 9% · 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

Height (Millimeter) · 94Width (Millimeter) · 94Length (Millimeter) · 94Length (Inch) · 16Height (Inch) · 5Width (Inch) · 5

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

How many pulse oximeter probe, reusable products are registered in the US?

4,454 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulse oximeter probe, reusable", from 64 companies. The largest labeler is Unimed Medical Supplies, Inc. with 52% of records.

Which FDA product codes apply?

DQA (Oximeter), OCH (Oximeter, Infrared, Sporting, Aviation), DPZ (Oximeter, ear), MHX (MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR)

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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