Data / Medical devices / Singapore / Healkee Medical Pte. Ltd.
Healkee Medical Pte. Ltd.: FDA-registered device maker in Singapore North West, Singapore, 2 510(k) clearances
Healkee Medical Pte. Ltd. is registered with the FDA (registration 3044735899) in Singapore North West, Singapore. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 23, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044735899
- Address
- 11 North Buona Vista Drive Level 08-09 The Metropolis Tower 2, Singapore North West, Singapore, 138589
- Owner or operator
- Healkee Medical Pte. Ltd. (10095452)
- Roles
- Specification developer
- First device listed
- March 19, 2026
- Registered through
- 2026
- Brand names listed
- AeroKEE Single-Use Colonoscopy Pants, AeroKEE Single-Use Endoscopic Procedure Mask, AirKEE P900, AirKEE T900
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | 2 | Specification developer | accessdata.fda.gov |
| Purifier, Air, Ultraviolet, Medical | FRA | 2 | 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 23, 2024 | K232642 | AirKEE T900 | FRA | Substantially Equivalent | Healkee Medical Pte, Ltd. | accessdata.fda.gov |
| May 16, 2024 | K232933 | AirKEE P900 | FRA | Substantially Equivalent | Healkee Medical Pte, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 23, 2024. 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.