Data / Medical devices / Singapore / CMT Health Pte. Ltd.
CMT Health Pte. Ltd.: FDA-registered device maker in Singapore, Singapore, 10 510(k) clearances
CMT Health Pte. Ltd. is registered with the FDA (registration 3036722184) in Singapore, Singapore. It lists 11 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 29, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3036722184
- Address
- 6001 Beach Road #19-13A Golden Mile Tower, Singapore, Singapore, 199589
- Owner or operator
- CMT HEALTH PTE. LTD. (10092915)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- March 6, 2025
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bladder Irrigation Kit | PPA | 2 | Specification developer | accessdata.fda.gov |
| Enteral Specific Transition Connectors | PIO | 2 | Specification developer | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Low Dead Space Piston Syringe | QNQ | 2 | Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Dental) | EIB | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | 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 |
|---|---|---|---|---|---|---|
| July 29, 2026 | K261829 | Profoject Dual-Safety Pen Needles | FMI | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
| July 15, 2026 | K260739 | Profoject Pen Needles (Model A; Model B) | FMI | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
| June 12, 2026 | K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | FMF | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
| June 10, 2026 | K260855 | Profoject Safety Pen Needles | FMI | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
| April 8, 2026 | K253268 | Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap | PNR | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
| February 23, 2026 | K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | FMF | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
| February 19, 2026 | K252814 | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe | QNQ | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
| October 16, 2025 | K252631 | Profoject Disposable Needle | FMI | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
| July 25, 2025 | K252033 | Profoject Disposable Syringe, Profoject Disposable Syringe with Needle | FMF | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
| July 18, 2025 | K251585 | Profoject Enteral Feeding Syringe | PNR | Substantially Equivalent | CMT Health PTE., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Low Dead Space Piston Syringe
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Needle, Aspiration And Injection, Disposable
Updated July 29, 2026. 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.