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Sign in to claim this brandVales & Hills Biomedical Tech. , Ltd.
US
Last updated May 31, 2026
What Vales & Hills Biomedical Tech. , Ltd. makes
Vales & Hills Biomedical Tech., Ltd. manufactures professional multichannel electrocardiograph systems, including ECG acquisition devices and Holter analysis systems designed for continuous cardiac monitoring.
Their portfolio consists of Class II medical devices authorised via FDA 510(k) and UDI registrations, and 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 Vales & Hills Biomedical Tech., Ltd. primarily manufacture?
Vales & Hills Biomedical Tech., Ltd. specialises in professional multichannel electrocardiograph systems. Their portfolio includes ECG acquisition devices and Holter analysis systems, such as the CV3000 HOLTER ANALYSIS SYSTEM, which are designed for continuous cardiac monitoring in clinical settings.
Where is Vales & Hills Biomedical Tech., Ltd. based?
The company is headquartered in the United States, where it operates as a manufacturer of its medical devices.
Which regulatory registries or databases list devices manufactured by Vales & Hills Biomedical Tech., Ltd.?
Devices from Vales & Hills Biomedical Tech., Ltd. are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries reflect their Class II medical devices, which require such authorisation pathways.
How are the devices produced by Vales & Hills Biomedical Tech., Ltd. classified under medical device regulations?
The company’s devices fall under Class II classification in the FDA’s regulatory framework. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as ECG systems used for cardiac monitoring.
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
- 527210612
Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ECG Acquisition Systems | iCV200S | FDA UDI | Class II | Active |
| ECG Acquisition Systems | iCV200(BLE) | FDA UDI | Class II | Active |
| ECG Acquisition Systems | K163607 | FDA 510(k) | Class II | Active |
| Cv3000 Holter Analysis System | K131897 | FDA 510(k) | Class II | Active |
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