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 Apheresis Needle Set	820-6019-33	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-1600-33	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1507	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-2531-33	FDA UDI	Class II	Active
JMS Sysloc A.V. Fistula Needle Set	824-1704	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-1800-33	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-1476-33	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-1564	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-2500-33	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1400-33	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-7002-33	FDA UDI	Class II	Active
Jms Rotating Hub A.v.fistula Needle Set	823-1635	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-2402-33	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-2644	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-6013-33	FDA UDI	Class II	Active
Jms Sysloc A.v.fistula Needle Set	824-1702-33	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-5002-33	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-2632-33	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-6015-33	FDA UDI	Class II	Active
Jms Sysloc Mini A.v. Fistula Needle Set	864-2702	FDA UDI	Class II	Active
Jms A.v.fistula Needle Set (single Type)	820-3605	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-1590	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-1500-33	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-2600-33	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-1648	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-5006-33	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-1802	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1402-33	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-7001-33	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1503-33	FDA UDI	Class II	Active
Jms A.v.fistula Needle Set (single Type)	820-3500	FDA UDI	Class II	Active
Jms Sysloc Mini A.v.fistula Needle Set	864-2800-33	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1500-33	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-1701	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1800-33	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-2717-33	FDA UDI	Class II	Active
Jms Harmony A.v.fistula Needle Set	827-1605	FDA UDI	Class II	Active
Jms A.v.fistula Needle Set	820-1469	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-7005-33	FDA UDI	Class II	Active
Jms Sysloc Apheresis Needle Set	824-1604-33	FDA UDI	Class II	Active
Jms Wingeater Apheresis Needle Set	820-5008-33	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-1704	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-1400-33	FDA UDI	Class II	Active
Jms Sysloc Mini A.v. Fistula Needle Set	864-1504	FDA UDI	Class II	Active
Jms Sysloc Mini A.v. Fistula Needle Set	864-1605	FDA UDI	Class II	Active
Jms A.v. Fistula Needle Set	820-1734	FDA UDI	Class II	Active
Jms Wingeater A.v.fistula Needle Set	820-1844-33	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-2400-33	FDA UDI	Class II	Active
Jms Sysloc Mini A.v. Fistula Needle Set	864-2502	FDA UDI	Class II	Active
Jms Sysloc Mini Avf Needle Set	864-2700-33	FDA UDI	Class II	Active

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