510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CMT Health Pte. Ltd.

Singapore, SG

CMT HEALTH PTE. LTD. appears in FDA device records in Singapore, SG. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for CMT Health Pte. Ltd. between 2025 and 2026. The busiest year on record is 2026, with 7. The most recent is 2026, with 7.

Clearances by year, as a table
510(k) clearance decisions for CMT Health Pte. Ltd., by decision year
YearClearances
20253
20267
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261829Profoject™ Dual-Safety Pen NeedlesFMISubstantially Equivalent
K260739Profoject™ Pen Needles (Model A; Model B)FMISubstantially Equivalent
K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleFMFSubstantially Equivalent
K260855Profoject™ Safety Pen NeedlesFMISubstantially Equivalent
K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes CapPNRSubstantially Equivalent
K253068Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin SyringeFMFSubstantially Equivalent
K252814Profoject™ 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 SyringeQNQSubstantially Equivalent
K252631Profoject™ Disposable NeedleFMISubstantially Equivalent
K252033Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with NeedleFMFSubstantially Equivalent
K251585Profoject™ Enteral Feeding SyringePNRSubstantially Equivalent

Registered establishments

FDA registered establishments for CMT Health Pte. Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30367221843036722184CMT HEALTH PTE. LTD.6001 Beach Road #19-13A Golden Mile Tower, Singapore 199589 SG2026and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain