FDA.reportPublic FDA data

YUWELL® Finger Pulse Oximeter

Primary DI
06933257922013
Brand
YUWELL® Finger Pulse Oximeter
Company
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
Model
YX310
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252805000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252805000YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-17DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06933257922013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06933257922013069332579220136933257922013

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn 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 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Regulatory Flags#

DUNS number
528704000
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06933257929432YUWELL® Infrared Ear ThermometerYHT108YHT1080012026-05-07
06933257930711YUWELL® Infrared Ear ThermometerYHT208YHT2080012026-05-07
06933257931213YUWELL® Infrared Ear ThermometerYHT202YHT2020012026-05-07
06933257931244YUWELL® Infrared Ear ThermometerYHT108YHT1080022026-05-07
06933257931251YUWELL® Infrared Ear ThermometerYHT202YHT2020022026-05-07
06933257931268YUWELL® Infrared Ear ThermometerYHT208YHT2080022026-05-07
06933257922006YUWELL® Finger Pulse OximeterYX1102026-05-06
06933257923171YUWELL® Finger Pulse OximeterYX1052026-05-06
06933257923188YUWELL® Finger Pulse OximeterYX1062026-05-06
06933257948488YUWELL Portable Oxygen ConcentratorSP-32026-02-24
06933257923133YUWELL® Infrared Ear ThermometerYHT1002025-09-05
06933257930636YUWELL® Infrared Ear ThermometerYHT1072025-09-05
06933257921948YUWELL®Finger Pulse OximeterYX1022025-06-16
06933257921955YUWELL® Finger Pulse OximeterYX1032025-06-16
06933257921993YUWELL® Finger Pulse OximeterYX3062025-06-16
06933257916593YUWELL Electronic Blood Pressure MonitorYE660F2025-06-12
06933257921634YUWELL Electronic Blood Pressure MonitorYE8800AR2025-06-12
06933257935419InogenVoxi 52025-06-11
06933257924925YUWELL Portable Oxygen ConcentratorSpirit-32025-06-10
06933257914124YUWELL Electronic Blood Pressure MonitorYE620B2025-06-09

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Primary DI, Brand, Company table
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08052990320691MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2025-12-19
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