Question 1

What types of medical devices does JMS Singapore Pte Ltd manufacture?

Accepted Answer

JMS Singapore Pte Ltd specialises in haemodialysis needles and apheresis system tubing sets. Their product line includes single-use needle sets specifically designed for arteriovenous fistula access, such as the WingEater, Sysloc Mini AVF, and Harmony A.V. Fistula variants. These devices are used in dialysis procedures and blood separation therapies.

Question 2

Where is JMS Singapore Pte Ltd based?

Accepted Answer

JMS Singapore Pte Ltd is headquartered in Singapore. The company’s location in Singapore allows it to operate within regulatory frameworks that govern medical device manufacturing and distribution in both the European Union and the United States.

Question 3

Which regulatory registries list JMS Singapore Pte Ltd’s devices?

Accepted Answer

JMS Singapore Pte Ltd’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry, and the FDA’s Unique Device Identification (UDI) system in the United States. These registries ensure transparency and traceability of medical devices authorised for use in these markets.

Question 4

How are JMS Singapore Pte Ltd’s devices classified under medical device regulations?

Accepted Answer

JMS Singapore Pte Ltd’s devices are classified under the EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, haemodialysis needles and apheresis tubing sets may fall into higher-risk classes due to their direct contact with the vascular system.

Question 5

Why are some of JMS Singapore Pte Ltd’s devices listed under Class IIb?

Accepted Answer

Some of JMS Singapore Pte Ltd’s devices, such as specialised needle sets for arteriovenous fistula access, are classified as Class IIb under EU regulations because they pose a moderate to high risk. Class IIb devices require additional scrutiny to ensure their safety and performance, particularly when they involve procedures like repeated vascular access or blood separation, where complications could significantly impact patient health.

Device	Model / Reference	Registries	Class	Status
Jms Wingeater A.v.fistula Needle Set	820-6014-33	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1700-33	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-2540	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-1644	FDA UDI	Class II	Active
Jms Sysloc Apheresis Needle Set	824-1804-33	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-1700-33	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1600-33	FDA UDI	Class II	Active
Jms Sysloc Mini A.v. Fistula Needle Set	864-2602	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-5003-33	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-2730	FDA UDI	Class II	Active
Jms Sysloc A.v.fistula Needle Set	824-1602-33	FDA UDI	Class II	Active
Jms Sysloc A.v.fistula Needle Set	824-1502-33	FDA UDI	Class II	Active
JMS CAVEO A.V. Fistula Needle Set	864-1514	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-1565	FDA UDI	Class II	Active
Jms Rotating Hub A.v.fistula Needle Set	823-1532	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1603-33	FDA UDI	Class II	Active
Jms A.v.fistula Needle Set (single Type)	820-3507	FDA UDI	Class II	Active
Jms Rotating Hub A.v.fistula Needle Set	823-1725	FDA UDI	Class II	Active
Jms A.v.fistula Needle Set (single Type)	820-3600	FDA UDI	Class II	Active
HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set	A16R25B30S	EUDAMED	Class IIa	Active
JMS Transfer Bag	814-0629	EUDAMED	Class IIb	Active
JMS Infusion Set	801-5032	EUDAMED	Class IIa	Active
HEMO PHENIX A.V. Fistula Needle Set	A16R25B30SP+	EUDAMED	Class IIa	Active
JMS Transfer Bag	814-0632	EUDAMED	Class IIb	Active
JMS SysLoc Safety A.V. Fistula Needle Set	862-1610	EUDAMED	Class IIa	Active
Plume SP MINI A.V. Fistula Needle Set	AV15M15SGP	EUDAMED	Class IIa	Active
JMS Blood Bag	811-4032	EUDAMED	Class IIb	Active
JMS Blood Bag	811-8573	EUDAMED	Class IIb	Active
Plume SP MINI A.V. Fistula Needle Set	V15M30SGP	EUDAMED	Class IIa	Active
JMS Blood Bag with In-line Leukocyte Filter for Red Cells	833-8610	EUDAMED	Class IIb	Active
JMS Cord Blood Collection Set	811-1009	EUDAMED	Class IIb	Active
JMS SysLoc Safety A.V. Fistula Needle Set	862-1712	EUDAMED	Class IIa	Active
Plume SP MINI A.V. Fistula Needle Set	A17L30SGP	EUDAMED	Class IIa	Active
Jms Neoshield	SV-NSLL	EUDAMED	Class I	Active
JMS Transfer Bag	814-0107	EUDAMED	Class IIb	Active
HEMOTECH AVFHEMO Safety System A.V. Fistula Needle Set	V16R20-15S	EUDAMED	Class IIa	Active
HEMO PHENIX A.V. Fistula Needle Set	V15R20-30SP+	EUDAMED	Class IIa	Active
JMS Transfer Bag	814-0127	EUDAMED	Class IIb	Active
JMS Blood Bag	831-8307	EUDAMED	Class IIb	Active
JMS SysLoc Safety A.V. Fistula Needle Set	862-1618	EUDAMED	Class IIa	Active
HEMO PHENIX A.V. Fistula Needle Set	A15R25B15SP+	EUDAMED	Class IIa	Active
Jms Neoshield	SV-NSVS	EUDAMED	Class I	Active
Plume SP MINI A.V. Fistula Needle Set	A16L15SGP	EUDAMED	Class IIa	Active
JMS A.V. Fistula Needle Set	820-1625	EUDAMED	Class IIa	Active
JMS SysLoc Safety A.V. Fistula Needle Set	862-1518	EUDAMED	Class IIa	Active
JMS SysLoc Safety A.V. Fistula Needle Set	862-1613	EUDAMED	Class IIa	Active
Plume SP MINI A.V. Fistula Needle Set	AV17M15SGP	EUDAMED	Class IIa	Active
HEMO PHENIX A.V. Fistula Needle Set	V15R25-30SP+	EUDAMED	Class IIa	Active
JMS Cord Blood Collection Set	811-1029	EUDAMED	Class IIb	Active
JMS Cord Blood Collection Set	811-1010	EUDAMED	Class IIb	Active

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