Device Explorer · FDA GUDID · GMDN 45607

Pulse oximeter

An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2

US‑registered devices1,094in commercial distribution
Companies148labelers on GUDID
Single‑use6%of device records
Sterile2%labelled sterile
Prescription37%Rx‑only share
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Share of device records

Beijing Choice Electronic Technology Co., Ltd.22420%
Contec Medical Systems Co., Ltd.747%
Nonin Medical, Inc.494%
Masimo Corporation394%
Shenzhen Jumper Medical Equipment Co.,Ltd.363%
Hunan Accurate Bio-Medical Technology Co., Ltd.363%
Hopkins Uniform Company333%
Shenzhen Creative Industry Co., Ltd.313%

Top labelers

CompanyDevicesShare
Beijing Choice Electronic Technology Co., Ltd.22420%
Contec Medical Systems Co., Ltd.747%
Nonin Medical, Inc.494%
Masimo Corporation394%
Shenzhen Jumper Medical Equipment Co.,Ltd.363%
Hunan Accurate Bio-Medical Technology Co., Ltd.363%
Hopkins Uniform Company333%
Shenzhen Creative Industry Co., Ltd.313%
Einstein Associates Llc293%
Shanghai Berry Electronic Tech Co., Ltd.272%
Shenzhen Viatom Technology Co.,Ltd.232%
Shenzhen Yimi Life- Technology Co.Ltd222%

Company = labeler of record on GUDID. 148 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NonagonFaceLakeConcordkingstLightning X Products,IncNAsimplicareIMDKYIMI LIFEAILE fingertip pulse oximeteracurioDR. SANASANTAMEDICALN/AMedisanaMediBio

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

FDA product codes

CodeNameDevices
DQAOximeter836
OCHOximeter, Infrared, Sporting, Aviation273
PGJOximeter, Wellness88
FLLThermometer, Electronic, Clinical9
DXNSystem, Measurement, Blood-Pressure, Non-Invasive8
DRGTransmitters And Receivers, Physiological Signal, Radiofrequ8

GMDN & GCC registration

  • GMDN code 45607 · non‑implantable
  • Single‑use 6% · sterile 2% · Rx‑only 37% · OTC 27%
  • 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) · 8Width (Millimeter) · 7Length (Millimeter) · 6Depth (Millimeter) · 3Width (Inch) · 2Length (Inch) · 2

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

How many pulse oximeter products are registered in the US?

1,094 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulse oximeter", from 148 companies. The largest labeler is Beijing Choice Electronic Technology Co., Ltd. with 20% of records.

Which FDA product codes apply?

DQA (Oximeter), OCH (Oximeter, Infrared, Sporting, Aviation), PGJ (Oximeter, Wellness), FLL (Thermometer, Electronic, Clinical)

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.

How do I get quotes?

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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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