FDA.reportPublic FDA data

AeviceMD

Primary DI
08883000007413
Brand
AeviceMD
Company
AEVICE HEALTH PTE. LTD.
Model
AeviceMD
Device description
The AeviceMD is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record and store lung sounds from pediatric patients aged 3 years and above in a clinical or non-clinical setting. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQDStethoscope, Electronic
DSHRecorder, Magnetic Tape, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQDStethoscope, ElectronicCardiovascular2
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223382000
K243603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223382000AeviceMDAevice Health Pte. , Ltd.2023-07-07DSH
K243603000AeviceMDAevice Health Pte. , Ltd.2025-05-05DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08883000007413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08883000007413088830000074138883000007413

GMDN Terms#

Term, Definition table
TermDefinition
Electronic acoustic stethoscopeAn external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].

Regulatory Flags#

DUNS number
595460609
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08883000003064AeviceMDSilicone Patch AE012026-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973660370001MinttiSuzhou Melodicare Medical Technology Co., Ltd.DQD2026-10-10
04250413405657ABPMpro SoftwareSOMNOmedics AGDSH2026-10-07
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DQD2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DQD2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DQD2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DQD2026-10-01
00810209880217CORE 300™ Digital Stethoscope - BlackEko Health, Inc.DQD2026-10-01
00810209880224CORE 300™ Digital Stethoscope - BerryEko Health, Inc.DQD2026-10-01
00810209880231CORE 300™ Digital Stethoscope - SunsetEko Health, Inc.DQD2026-10-01
00810209880248CORE 300™ Digital Stethoscope - PacificEko Health, Inc.DQD2026-10-01
00810209880255CORE 300™ Digital Stethoscope - CloudEko Health, Inc.DQD2026-10-01
P00020eWave Electrode PatchWearlinq, Inc.DSH2026-07-14
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-07-13
04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDSH2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDSH2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDSH2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDSH2026-07-07
04250413406470ABPMpro cuff for right armSOMNOmedics AGDSH2026-07-07
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-06-22
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-06-22
00810209880057CORE 500 Digital Stethoscope - Navy Blue EarpieceEko Health, Inc.DQD2026-06-12
00810209880064CORE 500 Digital Stethoscope - Military Green EarpieceEko Health, Inc.DQD2026-06-12
00810209880071CORE 500 Digital Stethoscope - Navy Blue BundleEko Health, Inc.DQD2026-06-12
00810209880088CORE 500 Digital Stethoscope - Military Green BundleEko Health, Inc.DQD2026-06-12
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DQD2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DQD2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DQD2026-06-03
00857522005125myPatch®DMS-SERVICE LLCDSH2026-05-06