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Sign in to claim this brandNewman Medical
US
Last updated September 17, 2026
What Newman Medical makes
Newman Medical manufactures non-invasive diagnostic devices for vascular and foetal monitoring, including reusable and single-use blood pressure cuffs, vascular ultrasound systems, and foetal Doppler probes. Their product line also includes portable Doppler systems designed for assessing foetal heart rates and blood flow in peripheral arteries. These devices are primarily used in clinical and home settings for cardiovascular and obstetric evaluations.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) and UDI pathways. Their products are listed in the FDA’s regulatory databases, ensuring compliance with US medical device standards. 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 Newman Medical manufacture?
Newman Medical specialises in non-invasive diagnostic devices used for vascular and foetal monitoring. Their product range includes reusable and single-use blood pressure cuffs, noninvasive vascular ultrasound systems, and foetal Doppler systems. These devices are designed for clinical and home use to assess blood flow in peripheral arteries and foetal heart rates, supporting cardiovascular and obstetric evaluations.
Where is Newman Medical based, and how does that affect its regulatory compliance?
Newman Medical is based in the United States, which means its devices are subject to FDA regulations. The company’s products are authorised through the FDA’s 510(k) pathway and carry Unique Device Identifiers (UDIs), ensuring compliance with US medical device standards. Being FDA-listed confirms their adherence to regulatory requirements for safety and performance.
Which regulatory registries list Newman Medical’s devices, and why is this important?
Newman Medical’s devices are listed in the FDA’s 510(k) and UDI registries. This inclusion is important because it confirms that each device has undergone the necessary premarket review process and carries a UDI for traceability, transparency, and compliance tracking. These registries help healthcare providers and regulators verify the authorised status of the devices.
How are Newman Medical’s devices classified under FDA regulations, and what does this classification mean?
Newman Medical’s devices are classified as Class II under FDA regulations. This classification indicates that they pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. While they don’t require premarket approval, they must still comply with FDA-mandated performance standards and labeling requirements to maintain their authorised status.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 5350 VIVIAN STREET, Arvada, CO, 80002
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3006265099
- DUNS Number
- —
Catalogue (95)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vasocuff | CUFF-220D | FDA UDI | Class II | Active |
| DigiDop | DD-701-D5 | FDA UDI | Class II | Active |
| Vasocuff | CUFF-SET-440 | FDA UDI | Class II | Active |
| simpleABI | ABI-600CL | FDA UDI | Class II | Active |
| DigiDop | DD-300-VASC | FDA UDI | Class II | Active |
| DigiDop | DD-701-D2W | FDA UDI | Class II | Active |
| DigiDop | DD-770R-D5 | FDA UDI | Class II | Active |
| Vasocuff | CUFF-SET-210D | FDA UDI | Class II | Active |
| DigiDop | DD-901-D3W | FDA UDI | Class II | Active |
| DigiDop | DD-700-OB | FDA UDI | Class II | Active |
| simpleABI | ABI-300 | FDA UDI | Class II | Active |
| simpleABI | ABI-250 | FDA UDI | Class II | Active |
| DigiDop | D2 | FDA UDI | Class II | Active |
| DigiDop | DD-300-D5 | FDA UDI | Class II | Active |
| DigiDop | DD-300-D3 | FDA UDI | Class II | Active |
| Vasocuff | CUFF-SET-242 | FDA UDI | Class II | Active |
| DigiDop | DD-901-D3 | FDA UDI | Class II | Active |
| DigiDop | DD-770-D2W | FDA UDI | Class II | Active |
| DigiDop | DD-700-VO | FDA UDI | Class II | Active |
| DigiDop | DD-301-D2W | FDA UDI | Class II | Active |
| Vasocuff | CUFF-240D | FDA UDI | Class II | Active |
| DigiDop | DD-301-D5 | FDA UDI | Class II | Active |
| DigiDop | DD-770A | FDA UDI | Class II | Active |
| DigiDop | D2W | FDA UDI | Class II | Active |
| DigiDop | DD-330-D2W | FDA UDI | Class II | Active |
| DigiDop | DD-770R-D2 | FDA UDI | Class II | Active |
| DigiDop | DD-300-D3W | FDA UDI | Class II | Active |
| DigiDop | DD-301-D3W | FDA UDI | Class II | Active |
| DigiDop | DD-330R | FDA UDI | Class II | Active |
| DigiDop | DD-330-D5 | FDA UDI | Class II | Active |
| DigiDop | DD-301-D8 | FDA UDI | Class II | Active |
| DigiDop | DD-770-D3 | FDA UDI | Class II | Active |
| DigiDop | DD-330R-D8 | FDA UDI | Class II | Active |
| Vasocuff | CUFF-210 | FDA UDI | Class II | Active |
| DigiDop | DD-700-D2 | FDA UDI | Class II | Active |
| DigiDop | DD-330R-D3W | FDA UDI | Class II | Active |
| DigiDop | DD-330A | FDA UDI | Class II | Active |
| DigiDop | DD-701-D2 | FDA UDI | Class II | Active |
| DigiDop | DD-700-VASC | FDA UDI | Class II | Active |
| DigiDop | DD-701-D8 | FDA UDI | Class II | Active |
| DigiDop | D3 | FDA UDI | Class II | Active |
| DigiDop | DD-770R-D2W | FDA UDI | Class II | Active |
| DigiDop | DD-PAD | FDA UDI | Class II | Active |
| Vasocuff | CUFF-210L | FDA UDI | Class II | Active |
| Simpleabi | K110628 | FDA 510(k) | Class II | Active |
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