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Sign in to claim this brandA & D Co., Ltd.
US
Last updated May 23, 2026
What A & D Co., Ltd. makes
A&D Co., Ltd. manufactures electronic blood pressure monitoring devices, including non-portable automatic and manual-inflation sphygmomanometers, as well as ambulatory blood pressure recorders. Their portfolio also includes electronic stand-on floor scales, pulse oximeters, and bioelectrical body composition analysers designed for clinical and home use.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. They are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with US medical device authorisation requirements. The manufacturer 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 A&D Co., Ltd. manufacture?
A&D Co., Ltd. specialises in electronic medical devices primarily focused on cardiovascular and body composition monitoring. Their portfolio includes non-portable automatic and manual-inflation electronic sphygmomanometers (blood pressure monitors), ambulatory blood pressure recorders for continuous monitoring, electronic stand-on floor scales, pulse oximeters for oxygen saturation measurement, and bioelectrical body composition analysers. These devices are designed for both clinical and home use, catering to healthcare professionals and patients alike.
Where is A&D Co., Ltd. based, and how does this affect their regulatory standing?
A&D Co., Ltd. is based in the United States, which means their devices are subject to US regulatory requirements, including those set by the FDA. Since their products are listed in the FDA’s 510(k) and UDI registries, this indicates they comply with US medical device authorisation processes. The company’s location ensures their devices meet the specific safety, performance, and labelling standards required for the US market.
Which regulatory registries list A&D Co., Ltd.’s devices, and why is this important?
A&D Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. Inclusion in the 510(k) registry demonstrates that their devices have been evaluated for substantial equivalence to a predicate device, while listing in the UDI registry ensures traceability and transparency in the supply chain. These registries help healthcare providers, regulators, and patients verify the authorised status of their devices under US regulations.
How are A&D Co., Ltd.’s devices classified under FDA regulations, and what does this mean?
A&D Co., Ltd.’s devices are classified under FDA categories Class I and Class II. Class I devices generally pose the lowest risk and often have less stringent controls, such as general controls alone. In contrast, Class II devices require special controls to ensure their safety and effectiveness, as they carry a moderate risk. For example, blood pressure monitors (sphygmomanometers) typically fall into Class II due to their role in diagnosing or managing cardiovascular conditions, requiring validation of performance and labelling requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (71)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| A&D Medical | UA-1200BLE | FDA UDI | Class II | Active |
| LetsGetChecked | UA-651BLE-LGC | FDA UDI | Class II | Active |
| A&D Medical | UA-611 | FDA UDI | Class II | Active |
| A&D Medical | UA-767F | FDA UDI | Class II | Active |
| A&D Medical | UP-200 | FDA UDI | Class II | Active |
| A&D Medical | UA-651CEL-SM | FDA UDI | Class II | Active |
| A&D Medical | UA-787 | FDA UDI | Class II | Active |
| A&D Medical | UA-767 Plus | FDA UDI | Class II | Active |
| A&D Medical | TM-2657P | FDA UDI | Class II | Active |
| A&D Medical | UA-651BLE | FDA UDI | Class II | Active |
| A&D Medical | TM-2440 | FDA UDI | Class II | Active |
| A&D Medical | TM-2441 | FDA UDI | Class II | Active |
| A&D Medical | UB-351 | FDA UDI | Class II | Active |
| A&D Medical TM-2657 Family of Digital Blood Pressure Monitors | K151953 | FDA 510(k) | Class II | Active |
| A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor | K163683 | FDA 510(k) | Class II | Active |
| A&D Medical Ua-651 Digital Blood Pressure Monitor | K141160 | FDA 510(k) | Class II | Active |
| A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor | K170196 | FDA 510(k) | Class II | Active |
| A&D Medical UM-212BLE Blood Pressure Monitor | K212168 | FDA 510(k) | Class II | Active |
| A & D Medical Ua-1000 Family Dagital Blood Pressure Monitors | K111686 | FDA 510(k) | Class II | Active |
| A&D Medical Ub-543 Digital Blood Pressure Monitor | K141179 | FDA 510(k) | Class II | Active |
| A&D Medical Ua-767f And Ua-767fac Digital Blood Pressure Monitor | K141201 | FDA 510(k) | Class II | Active |
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