Question 1

What types of medical devices does WickiMed (Hui Zhou) Medical Equipment Manufacturing Co., Ltd. primarily manufacture?

Accepted Answer

WickiMed (Hui Zhou) Medical Equipment Manufacturing Co., Ltd. produces single-use surgical scalpels designed for one-time medical procedures.

These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.

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

Question 2

Where is WickiMed (Hui Zhou) Medical Equipment Manufacturing Co., Ltd. based?

Accepted Answer

The company is based in the United States. While the name includes a reference to 'Hui Zhou,' the operational headquarters and regulatory presence are established within the US market.

Question 3

Which regulatory registries or databases list WickiMed’s devices?

Accepted Answer

WickiMed’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices authorized in the US market.

Question 4

How are WickiMed’s devices classified under FDA regulations?

Accepted Answer

WickiMed’s single-use surgical scalpels fall under Class II classification by the FDA. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
WickiMed	138505	FDA UDI	Class II	Active
WickiMed	138504-10	FDA UDI	Class II	Active
WickiMed	138505-10	FDA UDI	Class II	Active
WickiMed	138506-10	FDA UDI	Class II	Active
WickiMed	138506	FDA UDI	Class II	Active
WickiMed	138504	FDA UDI	Class II	Active

WickiMed (Hui Zhou) Medical Equipment Manufacturing Co., Ltd.

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