Data / Medical devices / Singapore / Aevice Health Pte. Ltd.
Aevice Health Pte. Ltd.: FDA-registered device maker in Singapore North East, Singapore, 2 510(k) clearances
Aevice Health Pte. Ltd. is registered with the FDA (registration 3042167640) in Singapore North East, Singapore. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042167640
- Address
- 3 Tai Seng Avenue, Tai Seng Exchange Tower B #04-32, Singapore North East, Singapore, 536465
- Owner or operator
- AEVICE HEALTH PTE LTD (10094174)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 17, 2025
- Registered through
- 2026
- Brand names listed
- AeviceMD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | DSH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stethoscope, Electronic | DQD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 5, 2025 | K243603 | AeviceMD | DSH | Substantially Equivalent | Aevice Health Pte. , Ltd. | accessdata.fda.gov |
| July 7, 2023 | K223382 | AeviceMD | DSH | Substantially Equivalent | Aevice Health Pte. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.