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Sign in to claim this brandZOE MEDICAL INCORPORATED
US
Last updated May 27, 2026
What ZOE MEDICAL INCORPORATED makes
ZOE Medical Incorporated manufactures clinical-grade systems for continuous monitoring of multiple vital physiological parameters, including devices like the Ultraview DM3 and the 740 SELECT. These systems are designed to track real-time data such as heart rate, blood pressure, and other critical metrics in healthcare settings. The DM4 is also part of their portfolio, offering similar monitoring capabilities for patient care environments.
The company’s devices fall under Class II regulatory classification in the US and are listed in the FDA’s Unique Device Identifier (UDI) database. These systems are intended for use in clinical settings and comply with applicable US regulatory requirements. 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 Zoe Medical Incorporated manufacture?
Zoe Medical Incorporated specializes in clinical-grade multiple vital physiological parameter monitoring systems. These devices are designed to continuously track critical patient metrics like heart rate and blood pressure in healthcare environments. Examples include the Ultraview DM3 and 740 SELECT, which provide real-time monitoring for patient care.
Where is Zoe Medical Incorporated based?
Zoe Medical Incorporated is headquartered in the United States. The company’s location influences its regulatory compliance with US standards, including device classification and reporting requirements.
How are Zoe Medical Incorporated’s devices classified in the US?
Zoe Medical Incorporated’s devices fall under Class II classification in the US regulatory system. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as monitoring systems for vital signs.
Are Zoe Medical Incorporated’s devices listed in any regulatory registries?
Yes, Zoe Medical Incorporated’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency for regulatory tracking, helping healthcare providers and authorities verify device details like manufacturer, model, and compliance status.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- zoemedical.com
- —
- —
- [email protected]
- Phone
- 978-887-4013
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 848429929
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ultraview DM3 | 91330-N | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XMF0W | FDA UDI | Class II | Active |
| Dm4 | 91331-N | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XNF00 | FDA UDI | Class II | Active |
| Ultraview DM3 | 91330-MT | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-0M000 | FDA UDI | Class II | Active |
| Dm4 | 91331-MF | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XM000 | FDA UDI | Class II | Active |
| Dm4 | 91331-MFW | FDA UDI | Class II | Active |
| Dm4 | 91331-M | FDA UDI | Class II | Active |
| Ultraview DM3 | 91330-M | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XM0E0 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-0N0E0 | FDA UDI | Class II | Active |
| Dm4 | 91331-MW | FDA UDI | Class II | Active |
| Dm4 | 91331-NF | FDA UDI | Class II | Active |
| Ultraview DM3 | 91330-NT | FDA UDI | Class II | Active |
| Dm4 | 91331-NW | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XN0E0 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XNFE0 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-X0A00 | FDA UDI | Class II | Active |
| Nightingale Monitoring System | Nightingale PPM3 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XN0EW | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-X0000 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XMAE0 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XM0EW | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XMFE0 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XNA00 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-0NF00 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XNAE0 | FDA UDI | Class II | Active |
| Dm4 | 91331-NFW | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XMA00 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XN000 | FDA UDI | Class II | Active |
| 740 Select | 740 SELECT-XMF00 | FDA UDI | Class II | Active |
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