FDA.reportPublic FDA data

CMT HEALTH PTE. LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30367221843036722184CMT HEALTH PTE. LTD.1N2026-01-016001 Beach Road #19-13A Golden Mile Tower Singapore SG 199589

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3378101367827452K261829Profoject™ Dual-Safety Pen NeedlesFMI2026-07-29
3378101473349843K260855Profoject™ Safety Pen NeedlesFMI2026-06-10
3378101900541345K260739Profoject™ Pen Needles (Model A; Model B)FMI2026-07-15
3378101165105915K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleFMF2026-06-12
3378101356336793K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes CapPNR2026-04-08
3378101163764858K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeFMF2026-02-23
3378101126672768K252814Profoject™ 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 SyringeQNQ2026-02-19
3378101669961940K252631Profoject™ Disposable NeedleFMI2025-10-16
3378101005357697K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleFMF2025-07-25
3378101314445041K251585Profoject™ Enteral Feeding SyringePNR2025-07-18
3378101224112892
3378101320142096
3378101330133503
3378101367529731
3378101757282953

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMI42026-07-29
FMF32026-06-12
PNR22026-04-08
QNQ12026-02-19