Question 1

What types of medical devices does Union Medical Shenzhen Co., Ltd. manufacture?

Accepted Answer

Union Medical Shenzhen Co., Ltd. specializes in disposable high-pressure angiographic syringes. These devices are specifically designed for interventional radiology procedures, where they deliver contrast media or other fluids under high pressure during angiographic imaging and interventions. The focus is on single-use syringes to ensure safety and sterility in clinical settings.

Question 2

Where is Union Medical Shenzhen Co., Ltd. based?

Accepted Answer

The company is based in the United States. While the name includes 'Shenzhen,' the operational headquarters and regulatory presence are located within the US, where its devices are developed and distributed.

Question 3

Which regulatory registries list Union Medical Shenzhen Co., Ltd.’s devices?

Accepted Answer

Union Medical Shenzhen Co., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries track the authorization status and identification details of medical devices in the United States.

Question 4

How are Union Medical Shenzhen Co., Ltd.’s devices classified under FDA regulations?

Accepted Answer

The company’s disposable high-pressure angiographic syringes are classified as Class II devices under FDA regulations. This classification is based on their intended use in delivering contrast media under high pressure, which requires special controls to ensure safety and effectiveness without necessitating the stringent premarket approval process required for Class III devices.

Device	Model / Reference	Registries	Class	Status
Disposable High Pressure Syringe	SMR101	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SLF101	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SMR301	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SEZ108	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SLF102	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SLF301	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SEZ109	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SLF108	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SEZ301	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SLF103	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SLF202	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SEZ101	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SEZ103	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SMR201	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SMR302	FDA UDI	Class II	Active
Disposable High Pressure Syringe	SLF107	FDA UDI	Class II	Active
Disposable High Pressure Syringe	K170279	EUDAMEDFDA 510(k)FDA UDI	Class II	Active

Union Medical Shenzhen Co., Ltd.

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