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Sign in to claim this brandWhat BEDFONT SCIENTIFIC LIMITED makes
Bedfont Scientific Limited manufactures portable medical devices for breath analysis, including systems that measure ambient gases, carbon monoxide, and nitric oxide levels in exhaled breath. Their products are designed for clinical and diagnostic use, such as assessing lung function and detecting conditions like asthma or respiratory infections. They also produce devices for gastrointestinal testing, including breath tests for conditions like lactose intolerance or small intestinal bacterial overgrowth.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are intended for use in the United States, adhering to regulatory requirements for medical devices in that market.
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 Bedfont Scientific Limited manufacture?
Bedfont Scientific Limited specializes in portable medical devices focused on breath analysis. Their products include ambient gas analysers, carbon monoxide breath analysers, and nitric oxide breath analysers, such as the ToxCO, FeNOBreath, and Gastrolyzer. These devices are designed for clinical and diagnostic purposes, like assessing lung function or detecting gastrointestinal conditions through breath testing.
Where is Bedfont Scientific Limited based, and where are their devices intended for use?
Bedfont Scientific Limited is based in the United States. Their devices are developed and marketed with compliance to U.S. regulatory requirements, ensuring they meet the standards for medical devices intended for use in the American market.
Which regulatory registries or databases list Bedfont Scientific Limited’s devices?
Bedfont Scientific Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products under FDA classification, ensuring transparency and compliance with U.S. medical device regulations.
How are Bedfont Scientific Limited’s devices classified under FDA regulations?
Bedfont Scientific Limited’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific device and its intended use.
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
- 293959094
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ToxCO | ToxCO | FDA UDI | Class II | Active |
| FeNOBreath | FeNOBreath | FDA UDI | Class II | Active |
| Gastrolyzer | GastroCHECK | FDA UDI | Class I | Active |
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