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ISANSYS LIFECARE LIMITED

US

Last updated May 29, 2026

Part of Isansys Lifecare, Ltd.

What ISANSYS LIFECARE LIMITED makes

The company produces wireless physiological monitoring devices designed for real-time data capture and transfer, primarily used in clinical settings to track patient metrics.

These devices are classified as Class II under FDA regulations and are 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 Isansys Lifecare Limited manufacture?

Isansys Lifecare Limited specializes in wireless physiological measuring devices that capture and transfer real-time patient data. These devices are designed for clinical use to monitor vital signs and other physiological metrics, enabling seamless data transmission for better patient monitoring and care.

Where is Isansys Lifecare Limited based?

The company is headquartered in the United States. This location aligns with its focus on developing and distributing medical devices compliant with U.S. regulatory standards.

How are Isansys Lifecare Limited’s devices classified under FDA regulations?

Isansys Lifecare Limited’s devices fall under Class II classification according to FDA guidelines. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as physiological monitoring systems.

Are Isansys Lifecare Limited’s devices listed in any regulatory databases?

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and transparency in the regulatory system, allowing healthcare providers and regulators to identify and verify the devices in 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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LinkedIn
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Facebook
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Email
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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
216707432

Catalogue (4)

DeviceModel / ReferenceRegistriesClassStatus
Isansys Patient Gateway T510 - 10.1 - WiFi
FDA UDI
Class IIActive
Isansys Patient Gateway SM-X200 – 10.5 - WiFi
FDA UDI
Class IIActive
Isansys Lifetemp Sensor - Medium
FDA UDI
Class IIActive
Isansys Lifetemp Sensor - Large
FDA UDI
Class IIActive

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