FDA.reportPublic FDA data

AeviceMD

Primary DI
08883000003064
Brand
AeviceMD
Company
AEVICE HEALTH PTE. LTD.
Model
Silicone Patch AE01
Device description
Contains 5 counts of silicone patches (refill) for housing of the AeviceMD sensor to the user's body.
Published
2026-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08883000003064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08883000003064088830000030648883000003064

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08883000007413AeviceMDAeviceMD2026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-05-18
08883000007413AeviceMDAEVICE HEALTH PTE. LTD.DQD2026-05-18
00857522005125myPatch®DMS-SERVICE LLCDSH2026-05-06
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-04-17
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Devices, Inc.DQD2026-04-03
00810209880026CORE 500 Digital Stethoscope FIGS Earpiece - Orange TaffyEko Devices, Inc.DQD2026-04-03
00850010298955CORE 500 Digital Stethoscope - Rose Gold ChestpieceEko Devices, Inc.DQD2026-04-03
00850010298962CORE 500 Digital Stethoscope - Rose Gold EarpieceEko Devices, Inc.DQD2026-04-03
00850010298979CORE 500 Digital Stethoscope - Bundle-ROGEko Devices, Inc.DQD2026-04-03
K00010eWave 6-Lead EKGWearlinq, Inc.DSH2026-04-02
P00010eWave Electrode PatchWearlinq, Inc.DSH2026-04-02
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2026-03-09
00860011561736Stethophone ProSparrow Acoustics Inc.DQD2026-02-18
00810209880002CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean BlueEko Devices, Inc.DQD2026-01-29
00810209880040EFAST (Eko Foundation Analysis Software with Transformers)Eko Devices, Inc.DQD2026-01-29
08809427311032SkeeperSmartsound CorportationDQD2026-01-12
17540279200027CardioSTATIcentia Inc.DSH2025-12-08
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-11-17
00850010298894CORE 500 Digital Stethoscope - Cool Blue ChestpieceEko Devices, Inc.DQD2025-11-07
00850010298900CORE 500 Digital Stethoscope - Cool Blue EarpieceEko Devices, Inc.DQD2025-11-07
08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
06429811134003Keikku Digital StethoscopeLapsi Health Holding B.V.DQD2025-10-16