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Sign in to claim this brandPERIGEN SOLUTIONS LTD
US
Last updated May 24, 2026
What PERIGEN SOLUTIONS LTD makes
Perigen Solutions Ltd develops software solutions focused on obstetrical monitoring and analysis, including tools for fetal heart rate pattern assessment and clinical decision support. Products such as PeriWatch Vigilance HUB and PeriCALM CheckList provide real-time monitoring and alert systems for perinatal care settings, while others like PeriCALM Curve and PeriWatch Vigilance Curve analyze fetal heart rate tracings for clinical interpretation.
The company’s portfolio is classified under FDA’s Class II medical devices and is listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to regulatory standards applicable to software-as-a-medical-device (SaMD) solutions in obstetrics.
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 Perigen Solutions Ltd manufacture?
Perigen Solutions Ltd specializes in software-based medical devices designed for obstetrical monitoring and analysis. Their products focus on fetal heart rate (FHR) assessment and clinical decision support, such as real-time monitoring systems (e.g., PeriWatch Vigilance HUB) and tools for analyzing FHR tracings (e.g., PeriCALM Curve). These solutions are intended to assist clinicians in perinatal care settings by providing alerts and interpretive insights.
Where is Perigen Solutions Ltd based, and how does this affect its regulatory compliance?
Perigen Solutions Ltd is based in the United States. As a U.S.-based manufacturer, its devices must comply with FDA regulations, including those for software-as-a-medical-device (SaMD). The company’s obstetrical monitoring software falls under FDA’s Class II classification, which requires adherence to specific controls, such as performance standards and post-market surveillance, to ensure safety and effectiveness in clinical use.
Which regulatory registries or databases list Perigen Solutions Ltd’s devices?
Perigen Solutions Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to medical devices to improve tracking, transparency, and regulatory oversight. Listing in this database helps ensure traceability and compliance with FDA requirements for Class II devices.
How are Perigen Solutions Ltd’s obstetrical monitoring devices classified by regulatory authorities?
Perigen Solutions Ltd’s devices are classified as Class II medical devices by the FDA. This classification applies to products that pose moderate risk and require special controls to ensure their safety and performance. For example, obstetrical monitoring software like PeriWatch Vigilance HUB or PeriCALM tools must meet performance standards and undergo rigorous validation to demonstrate their effectiveness in assessing fetal heart rate patterns and supporting clinical decisions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- perigen.com
- —
- —
- [email protected]
- Phone
- 8663216788
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 533337713
Catalogue (41)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PeriWatch Vigilance® HUB™ | 2024.1.xxx | FDA UDI | Class II | Active |
| PeriCALM® CheckList™ | 01.02.00 | FDA UDI | Class II | Active |
| PeriCALM® Curve™ | 02.06.00 | FDA UDI | Class II | Active |
| PeriCALM® Patterns™ | 02.08.xx | FDA UDI | Class II | Active |
| PeriWatch™ Vigilance™ | 01.00.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Curve™ | 2025.1.xxx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Curve™ | 2022.2.xxx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Cues™ | 2025.1.xxx | FDA UDI | Class II | Active |
| PeriCALM® Tracings™ | 03.18.04 | FDA UDI | Class II | Active |
| PeriCALM® Patterns™ | 02.06.00 | FDA UDI | Class II | Active |
| PeriWatch Vigilance® HUB™ | 21.01.xx | FDA UDI | Class II | Active |
| PeriWatch™ HUB™ | 01.01.xx | FDA UDI | Class II | Active |
| PeriWatch® Curve™ | 02.10.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance™ HUB™ | 01.04.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® HUB™ | 2024.2.xxx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Curve™ | 2024.2.xxx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Cues™ | 2024.1.xxx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® HUB™ | 2025.1.xxx | FDA UDI | Class II | Active |
| PeriWatch™ HUB™ | 01.02.xx | FDA UDI | Class II | Active |
| PeriWatch™ Vigilance™ Curve™ | 02.10.xx | FDA UDI | Class II | Active |
| PeriWatch™ Cues™ | 02.08.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Curve™ | 21.01.xx | FDA UDI | Class II | Active |
| PeriCALM® Tracings™, HUB Module | 01.00.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® HUB™ | 22.01.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® HUB™ | 01.05.xx | FDA UDI | Class II | Active |
| PeriWatch™ Vigilance™ HUB™ | 01.03.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Curve™ | 22.01.xx | FDA UDI | Class II | Active |
| PeriCALM® Patterns™ | 02.02.10 | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Cues™ | 02.12.xx | FDA UDI | Class II | Active |
| PeriWatch® Cues™ | 02.10.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Cues™ | 22.01.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Curve™ | 02.12.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Cues™ | 2024.2.xxx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Cues™ | 21.01.xx | FDA UDI | Class II | Active |
| PeriWatch™ Vigilance™ Cues™ | 02.10.xx | FDA UDI | Class II | Active |
| PeriCALM® Patterns™ | 02.04.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Cues™ | 2022.2.xxx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® Curve™ | 2024.1.xxx | FDA UDI | Class II | Active |
| PeriWatch™ Curve™ | 02.08.xx | FDA UDI | Class II | Active |
| PeriCALM® Curve™ | 02.08.xx | FDA UDI | Class II | Active |
| PeriWatch Vigilance® HUB™ | 2022.2.xxx | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- PeriGen Solutions Ltd. Rishon LeTziyon Central · IL FEI 3002687025