Q: What types of medical devices does Foshan United Medical Technologies Ltd. manufacture?

Foshan United Medical Technologies Ltd. specializes in wound care dressings. Their portfolio includes exudate-absorbent dressings with hydrophilic-gel technology, available in antimicrobial and non-antimicrobial variants, as well as nonadherent, absorbent dressings. These products are designed to manage wound exudate and promote healing.

Question 1

What types of medical devices does Foshan United Medical Technologies Ltd. manufacture?

Accepted Answer

Foshan United Medical Technologies Ltd. manufactures wound care dressings, including hydrophilic-gel products designed to absorb exudate with and without antimicrobial properties, as well as nonadherent, absorbent dressings for wound management.

Their portfolio includes devices authorised as Class I or Class II under FDA regulations, with submissions listed in the 510(k) and UDI registries. The company operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Foshan United Medical Technologies Ltd. based?

Accepted Answer

The company operates from the United States. While their manufacturing may occur elsewhere, their headquarters and regulatory submissions are associated with this location.

Question 3

Which regulatory registries list devices manufactured by Foshan United Medical Technologies Ltd.?

Accepted Answer

Devices from Foshan United Medical Technologies Ltd. are listed in the FDA’s 510(k) and UDI registries. These registries track submissions for Class I and Class II devices, which include their wound care dressings.

Question 4

How are the devices made by Foshan United Medical Technologies Ltd. classified under FDA regulations?

Accepted Answer

The devices produced by Foshan United Medical Technologies Ltd. are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like intended use and potential risk.

Device	Model / Reference	Registries	Class	Status
Sequa® Sorb	10x10cm	FDA UDI	Class I	Active
Sequa® Sorb	2.5x30cm	FDA UDI	Class I	Active
Sequa® Cel	15x15cm	FDA UDI	Class I	Active
Kytocel	15x15cm	FDA UDI	U	Active
Kytocel	10x10cm	FDA UDI	U	Active
Sequa® Sorb	5x5cm	FDA UDI	Class I	Active
Sequa® Cel	5x5cm	FDA UDI	Class I	Active
Sequa® Cel	2.5x45cm	FDA UDI	Class I	Active
Kytocel	5x5cm	FDA UDI	U	Active
Kytocel	2.5x45cm	FDA UDI	U	Active
Sequa® Sorb	10x20cm	FDA UDI	Class I	Active
Sequa® Cel	10x10cm	FDA UDI	Class I	Active
ALGS6 Ag Alginate Wound Dressing	K172570	FDA 510(k)	U	Active
ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC	K233111	FDA 510(k)	U	Active
KA01 Chitosan Wound Dressing	K143124	FDA 510(k)	U	Active

Foshan United Medical Technologies Ltd.

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