Question 1

What types of medical devices does Yiwu Ori-Power Medtech Co., Ltd. manufacture?

Accepted Answer

Yiwu Ori-Power Medtech Co., Ltd. specializes in first aid products, including medicated and non-medicated single-use first aid kits, adhesive bandages, and reusable cardiopulmonary resuscitation (CPR) masks. These devices are designed for emergency medical response and basic wound care, ensuring readiness for immediate medical needs.

Question 2

Where is Yiwu Ori-Power Medtech Co., Ltd. based?

Accepted Answer

The company operates from the United States. This location allows it to align with regulatory standards and manufacturing practices relevant to the US market, ensuring compliance with applicable device regulations.

Question 3

Which regulatory registries list Yiwu Ori-Power Medtech Co., Ltd.’s devices?

Accepted Answer

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices, ensuring transparency and traceability in the supply chain for regulatory and quality purposes.

Question 4

How are Yiwu Ori-Power Medtech Co., Ltd.’s devices classified?

Accepted Answer

The devices manufactured by Yiwu Ori-Power Medtech Co., Ltd. fall under Class I and non-classified (N) categories. Class I devices are generally considered low-risk and subject to fewer regulatory controls, while non-classified devices may not require formal classification due to their minimal risk profile or specific regulatory pathways.

Device	Model / Reference	Registries	Class	Status
OP - First aid series	OP300.632843.0038.007.0	FDA UDI	N	Active
OP - First aid series	OP3000193	FDA UDI	N	Active
OP - First aid series	OP30010663	FDA UDI	N	Active
OP - First aid series	OP3009729	FDA UDI	N	Active
OP - First aid series	OP3000396	FDA UDI	N	Active
OP - First aid series	32702.633996.0000.000.0	FDA UDI	Class I	Active
OP - First aid series	OP3009130	FDA UDI	N	Active
OP - First aid series	OP3000902	FDA UDI	Class I	Active
OP - First aid series	OP3009051	FDA UDI	N	Active
OP - First aid series	OP3000366	FDA UDI	N	Active
OP - First aid series	OP300.632318.0038.013.0	FDA UDI	N	Active
OP - First aid series	OP3000191	FDA UDI	N	Active
OP - First aid series	OP3000382	FDA UDI	Class I	Active
OP - First aid series	34101.632827.0000.000.0	FDA UDI	N	Active
OP - First aid series	OP3004665	FDA UDI	N	Active
OP - First aid series	OP300.630579.0566.013.0	FDA UDI	N	Active
OP - First aid series	OP3000922	FDA UDI	N	Active
OP - First aid series	OP3000486	FDA UDI	N	Active
OP - First aid series	OP3009183	FDA UDI	N	Active
OP - First aid series	OP0201194	FDA UDI	Class I	Active
OP - First aid series	OP3000088	FDA UDI	N	Active
OP - First aid series	OP3003070	FDA UDI	Class I	Active
OP - First aid series	OP3001208	FDA UDI	N	Active

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