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Sign in to claim this brandXiamen Acurio Instruments Co., Ltd.
US
Last updated May 23, 2026
What Xiamen Acurio Instruments Co., Ltd. makes
Xiamen Acurio Instruments manufactures the AS-3XX Series Fingertip Pulse Oximeter, a device for non-invasive monitoring of blood oxygen saturation and pulse rate, and the AT-6XX Series Infrared Thermometer, used for measuring body temperature via infrared detection.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
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 Xiamen Acurio Instruments Co., Ltd. manufacture?
Xiamen Acurio Instruments Co., Ltd. produces two primary medical devices: the AS-3XX Series Fingertip Pulse Oximeter, which monitors blood oxygen saturation and pulse rate non-invasively, and the AT-6XX Series Infrared Thermometer, designed to measure body temperature using infrared detection. These devices are intended for clinical and home use to track vital signs efficiently.
Where is Xiamen Acurio Instruments Co., Ltd. based?
The company is based in the United States. While the name may suggest an origin in China, the operational headquarters and regulatory presence are established within the US market.
How are Xiamen Acurio Instruments Co., Ltd.’s devices classified under FDA regulations?
The devices manufactured by Xiamen Acurio Instruments Co., Ltd., including the AS-3XX Series Fingertip Pulse Oximeter and the AT-6XX Series Infrared Thermometer, are classified as Class II under FDA regulations. This classification is based on their intended use and risk profile, requiring premarket notification via the 510(k) pathway to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Xiamen Acurio Instruments Co., Ltd.’s devices?
Xiamen Acurio Instruments Co., Ltd.’s devices are listed in the FDA’s 510(k) database, which tracks premarket notifications for Class II medical devices. This registry confirms their submission for market clearance, though it does not imply approval—only that the devices have undergone the required regulatory review process for their intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Santamedical | AS-301-L | FDA UDI | Class II | Active |
| Dr. Sana | AS-302-L | FDA UDI | Class II | Active |
| acurio | AS-302 | FDA UDI | Class II | Active |
| Santamedical | SM-ACLED150 | FDA UDI | Class II | Active |
| acurio | AS-302 | FDA UDI | Class II | Active |
| acurio | AS-301 | FDA UDI | Class II | Active |
| AS-3XX Series Fingertip Pulse Oximeter | K180685 | FDA 510(k) | Class II | Active |
| AT-6XX Series Infrared Thermometer | K171455 | FDA 510(k) | Class II | Active |
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