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Sign in to claim this brandWhat NEW N.I. MEDICAL (2011) LTD makes
New N.I. Medical (2011) Ltd manufactures impedance cardiographs, including the NICaS device, which measures cardiac output and related hemodynamic parameters using bioimpedance technology.
The company’s portfolio is regulated under Class II devices in the US and is listed in the FDA’s Unique Device Identifier (UDI) database. 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 New N.I. Medical (2011) Ltd manufacture?
New N.I. Medical (2011) Ltd specializes in impedance cardiographs, which are devices that measure cardiac output and hemodynamic parameters using bioimpedance technology. The most common device in their portfolio is the NICaS, designed for assessing heart function and circulation.
Where is New N.I. Medical (2011) Ltd based?
The company is headquartered in the United States. This location influences its regulatory compliance, particularly under US-based medical device regulations.
Which regulatory registries list New N.I. Medical (2011) Ltd’s devices?
New N.I. Medical (2011) Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products for regulatory and market surveillance purposes.
How are New N.I. Medical (2011) Ltd’s devices classified under US regulations?
The company’s devices fall under Class II classification in the US. This classification is assigned based on the level of risk associated with the device, where Class II devices require special controls to ensure safety and effectiveness beyond general controls.
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
- 600279405
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NICaS | CS | FDA UDI | Class II | Active |
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