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Sign in to claim this brandCITIZEN SYSTEMS JAPAN CO., LTD.
US
Last updated May 25, 2026
What CITIZEN SYSTEMS JAPAN CO., LTD. makes
Citizen Systems Japan manufactures non-portable automatic-inflation electronic sphygmomanometers designed for clinical and home blood pressure measurement. These devices include models such as the Blood Pressure Monitor CHU305 and CH-657, as well as the Blood Pressure Meter series (e.g., CH-101, CH-658, CH-609). The products are intended for repeated cuff-based blood pressure readings, typically used in healthcare settings or patient self-monitoring.
The company’s blood pressure monitors fall under FDA Class II regulation, with relevant devices authorised via the 510(k) pathway and listed under the FDA’s Unique Device Identifier (UDI) system. These products are commercially available in the United States, where the manufacturer is based.
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 Citizen Systems Japan manufacture?
Citizen Systems Japan specializes in non-portable automatic-inflation electronic sphygmomanometers. These devices are designed for clinical and home use to measure blood pressure through repeated cuff-based readings. Examples include models like the Blood Pressure Monitor CHU305, CH-657, and the Blood Pressure Meter series (e.g., CH-101, CH-658). The focus is on blood pressure monitoring for both healthcare professionals and patients.
Where is Citizen Systems Japan based, and where are its devices primarily used?
Citizen Systems Japan is based in the United States. While the company is headquartered there, its blood pressure monitoring devices are commercially available in the US market. The devices are intended for use in clinical settings as well as for patient self-monitoring at home, ensuring broad accessibility for blood pressure measurement.
Which regulatory registries or databases list Citizen Systems Japan’s devices?
Citizen Systems Japan’s devices are listed in the FDA’s 510(k) registry and the FDA’s Unique Device Identifier (UDI) system. These registries track authorised medical devices in the United States, ensuring transparency and compliance with regulatory requirements for blood pressure monitors like the CHU305 and CH-657 series.
How are Citizen Systems Japan’s blood pressure monitors classified under FDA regulations?
Citizen Systems Japan’s blood pressure monitors fall under FDA Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness. The company’s devices are authorised through the 510(k) pathway, which demonstrates that they meet regulatory standards for non-portable automatic-inflation electronic sphygmomanometers.
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
- 711510540
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Blood Pressure Monitor CHU305 | CHU305V | FDA UDI | Class II | Active |
| Blood Pressure Monitor CH-657 | CH657V1 | FDA UDI | Class II | Active |
| Blood Pressure Monitor CH-4532 | CH4532V-PB | FDA UDI | Class II | Active |
| Blood Pressure Meter Model Ch-101 | K100553 | FDA 510(k) | Class II | Active |
| Blood Pressure Meter, Model Ch-658 | K102303 | FDA 510(k) | Class II | Active |
| Blood Pressure Meter, Model Ch-609 | K100055 | FDA 510(k) | Class II | Active |
| Blood Pressure Meter, Model Ch-4532 | K093931 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Citizen Systems Japan Co., Ltd. NISHI-TOKYO-SHI · JP FEI 3005176386