Question 1

What types of medical devices does Ningbo Medsun Medical Co., Ltd. manufacture?

Accepted Answer

Ningbo Medsun Medical Co., Ltd. produces three primary types of medical devices: single-use blood lancets for capillary blood sampling, reusable manual blood lancing devices for diabetic testing, and autoinjector needles for prefilled medication delivery. These devices are designed for both clinical and home-use settings, such as glucose monitoring and insulin administration.

Question 2

Where is Ningbo Medsun Medical Co., Ltd. based?

Accepted Answer

The company operates from the United States. While the name suggests a Chinese origin, its manufacturing and business activities are conducted within the US market.

Question 3

Which regulatory registries list devices manufactured by Ningbo Medsun Medical Co., Ltd.?

Accepted Answer

Devices produced by Ningbo Medsun Medical Co., Ltd. are recorded in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices authorised for use in the US.

Question 4

How are devices from Ningbo Medsun Medical Co., Ltd. classified in the US?

Accepted Answer

All listed devices from Ningbo Medsun Medical Co., Ltd. fall under Class II regulatory classification in the US. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as blood lancets and autoinjector needles.

Device	Model / Reference	Registries	Class	Status
Medsun	ST 0.30mm×5mm	FDA UDI	Class II	Active
Medsun	CX11B2	FDA UDI	Class II	Active
Genteel	BYY4 26G	FDA UDI	Class II	Active
Genteel	BYY4 26G	FDA UDI	Class II	Active
Medsun	XH1 21G	FDA UDI	Class II	Active
Medsun	BYC 28G	FDA UDI	Class II	Active
Clarity	XH1 28G	FDA UDI	Class II	Active
Medsun	XH1 Blade 1.5mm	FDA UDI	Class II	Active
Medsun	CX11B1	FDA UDI	Class II	Active
Medsun	CT 0.30mm×5mm	FDA UDI	Class II	Active
Medsun	BYB 28G	FDA UDI	Class II	Active
Medsun	XY1 Blade 1.2mm	FDA UDI	Class II	Active
Medsun	BYY4 28G	FDA UDI	Class II	Active
Medsun	CX11C1	FDA UDI	Class II	Active
Medsun	BYY3 28G	FDA UDI	Class II	Active
Medsun	CX11C2	FDA UDI	Class II	Active
Medsun	XA1 21G	FDA UDI	Class II	Active
Medsun	XY1 21G	FDA UDI	Class II	Active

Ningbo Medsun Medical Co., Ltd.

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