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Sign in to claim this brandGuangdong Long Yao Electronic Technology Co., Ltd.
US
Last updated May 27, 2026
What Guangdong Long Yao Electronic Technology Co., Ltd. makes
The company manufactures line-powered pulse oximeters, which are medical devices used to measure oxygen saturation levels in the blood and heart rate. These devices are designed for clinical and patient monitoring applications, providing real-time data on vital signs. The portfolio includes models such as the iOX, eox, iox, and a generic Pulse Oximeter, all focused on non-invasive monitoring of oxygen levels.
The devices fall under FDA Class II regulation, requiring premarket notification (510(k)) submissions and compliance with the FDA’s Unique Device Identifier (UDI) system. They are listed in the FDA’s regulatory databases, ensuring adherence to U.S. medical device standards. The company operates within the United States, adhering to domestic regulatory requirements for these Class II products.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Guangdong Long Yao Electronic Technology Co., Ltd. manufacture?
Guangdong Long Yao Electronic Technology Co., Ltd. specializes in line-powered pulse oximeters. These devices are used to measure oxygen saturation levels in the blood and heart rate, primarily for clinical and patient monitoring purposes. The focus is on non-invasive monitoring to provide real-time vital sign data.
Where is Guangdong Long Yao Electronic Technology Co., Ltd. based?
The company is based in the United States. This location influences its regulatory compliance, as it must adhere to U.S. medical device standards and requirements for the devices it manufactures.
Which regulatory registries or databases list the devices made by Guangdong Long Yao Electronic Technology Co., Ltd.?
The company’s devices are listed in the FDA’s premarket notification (510(k)) database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure compliance with U.S. regulatory requirements for Class II medical devices, including pulse oximeters.
How are the devices manufactured by Guangdong Long Yao Electronic Technology Co., Ltd. classified under U.S. regulations?
The devices fall under FDA Class II classification. This classification requires manufacturers to submit a 510(k) premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness before commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 544492017
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iOX | LYOX01 | FDA UDI | Class II | Active |
| eox | LYOX01 | FDA UDI | Class II | Active |
| iox | LYOX01 | FDA UDI | Class II | Active |
| Pulse Oximeter | K201294 | FDA 510(k) | Class II | Active |
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