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Sign in to claim this brandRemote Diagnostic Technologies Limited
US
Last updated May 24, 2026
What Remote Diagnostic Technologies Limited makes
Remote Diagnostic Technologies Limited manufactures clinical-grade systems for continuous monitoring of multiple vital physiological parameters, including integrated physiologic-monitoring and defibrillation capabilities. Their devices are designed for real-time patient data acquisition in critical care settings, supporting applications such as cardiac monitoring and emergency response. The Tempus Pro and Tempus LS-Manual are among the systems used for these purposes, alongside third-party software like Philips IntelliSpace Corsium for data analysis.
The company’s products fall under FDA Class II devices, requiring pre-market submissions via 510(k) clearances or De Novo pathways where applicable. These devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer operates from 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 Remote Diagnostic Technologies Limited manufacture?
Remote Diagnostic Technologies Limited specializes in clinical-grade systems for continuous monitoring of multiple vital physiological parameters. Their devices include standalone systems like the Tempus Pro and Tempus LS-Manual, which combine physiologic monitoring with defibrillation capabilities. They also integrate with third-party software, such as Philips IntelliSpace Corsium, for advanced data analysis. These systems are designed for critical care environments, enabling real-time patient monitoring in settings like emergency response and cardiac care.
Where is Remote Diagnostic Technologies Limited based?
The company is headquartered in the United States. This location influences its regulatory compliance, particularly with U.S. authorities like the FDA, which governs the classification and submission requirements for its devices.
Which regulatory registries list Remote Diagnostic Technologies Limited’s devices?
Remote Diagnostic Technologies Limited’s devices are included in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries are used to track and verify the regulatory status of medical devices in the U.S., including their classification and compliance pathways.
How are Remote Diagnostic Technologies Limited’s devices classified by the FDA?
The company’s devices fall under FDA Class II classification. This classification requires manufacturers to demonstrate substantial equivalence to a predicate device through pre-market submissions, such as 510(k) clearances or De Novo pathways when no predicate exists. Class II devices are considered to have an acceptable level of risk that can be managed through general or special 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
- 896707940
Catalogue (57)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tempus Pro | 00-1024-R | FDA UDI | Class II | Active |
| Tempus Pro | 01-2114 | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1024-R | FDA UDI | Class II | Active |
| Tempus IC2 | 00-2001-R | FDA UDI | Class II | Unknown |
| Tempus LS-Manual | 01-3025 | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2111 | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1004-R | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1034-R | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1007-R | FDA UDI | Class II | Unknown |
| Tempus IC | 01-1010 | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1026-R | FDA UDI | Class II | Active |
| Tempus Pro | 01-2068 | FDA UDI | Class II | Active |
| Tempus LS-Manual | 01-3021 | FDA UDI | Class II | Active |
| Tempus Pro | 01-2002 | FDA UDI | Class II | Active |
| Philips IntelliSpace Corsium | 01-2507 | EUDAMEDFDA UDI | Class II | Active |
| Tempus Pro | 01-2003 | FDA UDI | Class II | Active |
| Tempus Pro | 01-2017 | EUDAMEDFDA UDI | Class II | Active |
| Tempus LS-Manual | 01-3022 | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2501 | FDA UDI | Class II | Active |
| Tempus Pro | 01-2049 | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1004-R | FDA UDI | Class II | Active |
| Tempus Pro | 01-2053 | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2179 | FDA UDI | Class II | Active |
| Tempus Pro | 01-2101 | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2203 | FDA UDI | Class II | Active |
| Tempus LS-Manual | 01-3023 | FDA UDI | Class II | Active |
| Tempus Pro | 01-2182 | FDA UDI | Class II | Active |
| Tempus Pro | 01-2110 | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-1012 | FDA UDI | Class II | Unknown |
| Tempus IC2 | 00-2001-R | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2004 | FDA UDI | Class II | Active |
| Tempus IC | 00-1001 | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2184 | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2177 | FDA UDI | Class II | Active |
| Tempus Pro | 00-1006 | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1005 | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1004 | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1036-R | FDA UDI | Class II | Unknown |
| Tempus Pro | 00-1007-R | FDA UDI | Class II | Active |
| Tempus IC2 | 01-2506 | EUDAMEDFDA UDI | Class II | Active |
| Tempus Pro | 00-1026-R | FDA UDI | Class II | Active |
| Tempus LS-Manual | 01-3020 | FDA UDI | Class II | Active |
| Tempus IC2 | 00-2001-T | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2186 | EUDAMEDFDA UDI | Class II | Active |
| Tempus IC2 | 01-2020 | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2069 | FDA UDI | Class II | Active |
| Tempus IC | 01-1005 | FDA UDI | Class II | Unknown |
| Tempus Pro | 01-2070 | FDA UDI | Class II | Active |
| Tempus IC | 01-1017 | FDA UDI | Class II | Unknown |
| Tempus IC | 01-1020 | FDA UDI | Class II | Unknown |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Remote Diagnostic Technologies Ltd. FARNBOROUGH Hampshire · GB FEI 3003832357