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Sign in to claim this brandARIBEX, INC.
US
Last updated May 27, 2026
What ARIBEX, INC. makes
Aribex, Inc. manufactures portable diagnostic x-ray systems designed for handheld use, including models like the NOMAD MD™ and NOMAD Pro 2™. These devices are intended for on-site imaging in clinical, dental, and field settings, providing real-time radiographic capabilities without requiring fixed infrastructure. Variations include packaged systems tailored for specific regional markets, such as the US, Canada, and the UK.
The company’s handheld x-ray systems fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) and compliance with the Unique Device Identifier (UDI) system. These devices are listed in the FDA’s 510(k) and UDI registries, adhering to US medical device regulations. 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 Aribex, Inc. manufacture?
Aribex, Inc. specializes in portable diagnostic x-ray systems designed for handheld use. Their primary product category is diagnostic x-ray system generators, hand-held, including models like the NOMAD MD™ and NOMAD Pro 2™. These devices are intended for on-site imaging in clinical, dental, and field settings, offering real-time radiographic capabilities without the need for fixed infrastructure. The company also produces packaged system variations tailored for specific regional markets, such as the US, Canada, and the UK.
Where is Aribex, Inc. based, and how does that affect its regulatory oversight?
Aribex, Inc. is based in the United States, which means its devices are subject to US regulatory requirements. Since the company’s handheld x-ray systems fall under Class II classification, they require premarket notification (510(k)) clearance and compliance with the Unique Device Identifier (UDI) system before commercial distribution. The FDA’s 510(k) and UDI registries list these devices, ensuring they meet US medical device regulations.
Which regulatory registries list Aribex, Inc.’s devices, and why?
Aribex, Inc.’s devices are listed in the FDA’s 510(k) and UDI registries. This is because Class II medical devices in the US require premarket notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device. Additionally, the UDI system ensures traceability and identification of these devices throughout their lifecycle, supporting regulatory compliance and patient safety tracking.
How are Aribex, Inc.’s handheld x-ray systems classified under US regulations?
Aribex, Inc.’s handheld x-ray systems are classified as Class II devices under US regulations. This classification applies because these systems involve moderate risk—while they are portable and intended for on-site use, they still require ionizing radiation controls and performance standards to ensure safety and effectiveness. As a result, they must undergo 510(k) premarket notification and comply with the UDI system before being marketed in the US.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- aribex.com
- —
- —
- [email protected]
- Phone
- +18663405522
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 169065526
Catalogue (24)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NOMAD MD™ handheld X-ray system | 1.011.5278 | FDA UDI | Class II | Active |
| NOMAD™ handheld X-ray system | 0.850.0015 | FDA UDI | Class II | Active |
| NOMAD MD™ handheld X-ray system | 0.850.0470 | FDA UDI | Class II | Active |
| NOMAD Pro 2™ | 0.850.0026 | FDA UDI | Class II | Active |
| Packaged System, Kavo Nomad Pro2, US | 1.013.2040 | FDA UDI | Class II | Active |
| NOMAD™ handheld X-ray system | 0.850.0001 | FDA UDI | Class II | Active |
| NOMAD™ handheld X-ray system | 0.850.0003 | FDA UDI | Class II | Active |
| NOMAD MD™ handheld X-ray system | 0.850.0471 | FDA UDI | Class II | Active |
| Packaged System, KaVo Nomad Pro2, CA | 1.013.7789 | FDA UDI | Class II | Active |
| NOMAD™ handheld X-ray system | 0.850.0004 | FDA UDI | Class II | Active |
| NOMAD Pro 2™ | 0.850.0025 | FDA UDI | Class II | Active |
| Packaged System, Kavo Nomad Pro2, GBL | 1.013.2041 | FDA UDI | Class II | Active |
| NOMAD MD™ handheld X-ray system | 0.850.0030 | FDA UDI | Class II | Active |
| NOMAD Pro 2™ | 0.850.0022 | FDA UDI | Class II | Active |
| NOMAD Pro 2™ | 0.850.0021 | FDA UDI | Class II | Active |
| NOMAD™ handheld X-ray system | 0.850.0000 | FDA UDI | Class II | Active |
| NOMAD™ handheld X-ray system | 0.850.0042 | FDA UDI | Class II | Active |
| NOMAD Pro 2™ | 0.850.0028 | FDA UDI | Class II | Active |
| NOMAD™ handheld X-ray system | 0.850.0002 | FDA UDI | Class II | Active |
| NOMAD MD™ handheld X-ray system | 0.850.0112 | FDA UDI | Class II | Active |
| KaVo NOMAD Pro 2 Handheld X-ray System | K173319 | FDA 510(k) | Class II | Active |
| Nomad Dental X-Ray System | K051795 | FDA 510(k) | Class II | Active |
| Nomad Pro X-Ray System | K081664 | FDA 510(k) | Class II | Active |
| Nomad Md 75k V Handheld X-Ray System | K140723 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Aribex, Inc. has two recall records, both initiated on July 18, 2016, and all listed with a terminated status. The recalls pertain to customer complaints regarding Nomad Pro and Pro 2 handsets, where users reported devices experiencing overheating, melting, smoking, or igniting due to internal lithium-ion batteries entering thermal runaway from a short circuit.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 18, 2016 | Z-2716-2016 | — | terminated | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB. |
| Jul 18, 2016 | Z-2717-2016 | — | terminated | Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB. |