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Amico Diagnostic Incorporated

US Last updated 24 May 2026

Devices
260
Registries
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FDA recalls
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Registered with the FDA under this company group, matched by name.

  • Amico Diagnostic Incorporated Richmond Hill Ontario · CA FEI 3009685433

What Amico Diagnostic Incorporated makes

Amico Diagnostic Incorporated manufactures manual and electronic blood pressure measurement devices, including aneroid sphygmomanometers, reusable blood pressure cuffs, and manual cuff inflators. Their portfolio also includes direct ophthalmoscopes for eye examinations and patient thermometers, such as intermittent electronic and infrared (ear) models. Some products are designed for clinical use, such as wall-mounted stations and rollstands for blood pressure monitoring, while others are standalone components like cuffs and cuff inflators.

The company’s devices are regulated under the US Food and Drug Administration (FDA) as Class I and Class II medical devices, with some authorised through the 510(k) premarket notification process and others listed under the Unique Device Identifier (UDI) system. These products are intended for use in clinical, home, and professional settings, adhering to FDA compliance requirements for their respective classifications.

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 Amico Diagnostic Incorporated manufacture?

Amico Diagnostic Incorporated specialises in manual and electronic devices primarily for blood pressure measurement, such as aneroid sphygmomanometers and reusable blood pressure cuffs. Their portfolio also includes manual cuff inflators, direct ophthalmoscopes for eye examinations, and patient thermometers like intermittent electronic and infrared (ear) models. Some products are designed as standalone components, while others are integrated into clinical monitoring stations like wall-mounted or rollstand systems.

Where is Amico Diagnostic Incorporated based?

Amico Diagnostic Incorporated is based in the United States. The company’s devices are regulated under the FDA’s jurisdiction, reflecting their US market focus.

Which regulatory registries or databases list Amico Diagnostic Incorporated’s devices?

Amico Diagnostic Incorporated’s devices are authorised and tracked through the FDA’s 510(k) premarket notification process for certain Class I and Class II products, as well as the Unique Device Identifier (UDI) system, which standardises device identification for traceability and compliance. These registries ensure transparency in the regulatory approval and monitoring of their authorised products.

How are Amico Diagnostic Incorporated’s devices classified under FDA regulations?

Amico Diagnostic Incorporated’s devices fall into Class I and Class II categories under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) clearance or UDI listing, ensuring compliance with applicable standards.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Phone
1-877-264-2697
DUNS number
203163290