Aevice Health Pte. Ltd.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3042167640	3042167640	Aevice Health Pte. Ltd.	1	N	2026-01-01	3 Tai Seng Avenue, Tai Seng Exchange Tower B #04-32 Singapore North East SG 536465

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
343974	1555153785	K243603	AeviceMD	DSH	2025-05-05
343974	1493408513	K223382	AeviceMD	DSH	2023-07-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DSH	2	2025-05-05

GUDID#

AeviceMD - Contains 5 counts of silicone patches (refill) for housing of the AeviceMD sensor to the user's body.
AEVICE HEALTH PTE. LTD.
2026-06-22
AeviceMD - 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.
AEVICE HEALTH PTE. LTD.
2026-05-18