Data / Medical devices / Singapore / JMS Singapore Pte. Ltd

JMS Singapore Pte. Ltd: FDA-registered device maker in SINGAPORE Central Singapore, Singapore, 7 510(k) clearances

Name: JMS Singapore Pte. Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

JMS Singapore Pte. Ltd is registered with the FDA (registration 3002807350) in SINGAPORE Central Singapore, Singapore. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated August 15, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3002807350
Address: 440 Ang Mo Kio Indus. Park 1, SINGAPORE Central Singapore, Singapore, 569620
Owner or operator: JMS SINGAPORE PTE. LTD (9044721)
Roles: Contract manufacturer, Manufacturer
First device listed: November 30, 2007
Registered through: 2027
Brand names listed: Haemonetics PCS2, JMS A.V. Fistula Needle Set ¿WingEater®¿., JMS Apheresis Needle Set ¿WingEater®¿, JMS CAVEO A.V. Fistula Needle Set, JMS RH, FW A.V. FISTULA NEEDLE SET, JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Manufacturer	accessdata.fda.gov
Needle, Fistula	FIE	2	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Contract manufacturer	accessdata.fda.gov
Separator, Automated, Blood Cell, Diagnostic	GKT	2	Contract manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer	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
August 15, 2025	K251877	JMS CAVEO A.V. Fistula Needle Set	FIE	Substantially Equivalent	JMS North America Corporation	accessdata.fda.gov
May 13, 2015	K151017	JMS Harmony A.V. Fistula Needle Set	FIE	Substantially Equivalent	JMS North America Corporation	accessdata.fda.gov
December 23, 2014	K142564	JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)	FIE	Substantially Equivalent	JMS North America Corporation	accessdata.fda.gov
October 27, 2011	K112178	JMS APHERESIS NEEDLE SET WINGEATER(R) V2	FIE	Substantially Equivalent	JMS North America Corporation	accessdata.fda.gov
October 24, 2011	K111948	WINGEATER V2	FIE	Substantially Equivalent	JMS North America Corporation	accessdata.fda.gov
August 18, 2003	K030479	JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET	FOZ	Substantially Equivalent	Jms North America Corp.	accessdata.fda.gov
April 10, 2000	K000845	MODIFICATION TO JMS A.V. FISTULA NEEDLE SET	FIE	Substantially Equivalent	Jms Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 15, 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.