Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003895440

FEI Number

3003895440

Entity Name

PT JMS BATAM

City/State/Country

BATAM Kepulauan Riau, ID

Establishment Address

LOT 211 JALAN BERINGIN, BATAMINDO IND.PARK MUKA KUNING, BATAM Kepulauan Riau 29433, ID

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JMS SINGAPORE PTE. LTD (Owner Number: 9044721)

Owner / Operator Contact Address

440 ANG MO KIO INDUSTRIAL PARK 1, SINGAPORE, SG-NOTA 569620, SG

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

JMS RH, FW A.V. FISTULA NEEDLE SET JMS Apheresis Needle Set ¿WingEater®¿ JMS CAVEO A.V. Fistula Needle Set Haemonetics PCS2 JMS RH, FW APHERESIS NEEDLE SET JMS A.V. Fistula Needle Set ¿WingEater®¿. JMS HARMONY BLUNT NEEDLE SET

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2007-11-30
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2011-11-02
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2011-11-02
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2015-03-11
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2015-03-11
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2025-08-24
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-11-21
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2010-01-27
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2015-05-21
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2011-10-31
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2010-02-24
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2010-02-16

Official Correspondent

No official correspondent registered.

US Agent Details

Sho Hosoki Business: JMS North America Corp. Email: shosoki@jmsna.net Phone: (510) 8889090

Related Public Records

Same Entity

JMS SINGAPORE PTE. LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002807350	JMS SINGAPORE PTE. LTD	SINGAPORE Central Singapore, SG

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915174	Jms Co., Ltd.	JMS APHERESIS NEEDLE	1993-03-02
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24

Similar Registrations

Registration Number	Establishment Name	Location
3010413216	SIAM STERI SERVICES CO., LTD	Panthong Chon Buri, TH
3002807350	JMS SINGAPORE PTE. LTD	SINGAPORE Central Singapore, SG
3003464075	NXSTAGE MEDICAL, INC.	LAWRENCE, MA, US
3013217742	BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD.	Guangzhou Guangdong, CN
9616419	SUNDER BIOMEDICAL TECH. CO., LTD.	Yunlin County, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003895440. Last updated year: 2026. Please use registration number 3003895440 when referencing this establishment in official correspondence.