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Sign in to claim this brandMagnamed Tecnologia Medica S/A
US
Last updated May 23, 2026
What Magnamed Tecnologia Medica S/A makes
Magnamed Tecnologia Medica S/A manufactures the Oxymag, a transport and emergency ventilator designed for critical care settings. This device supports mechanical ventilation in patients requiring respiratory assistance during transport or acute emergencies.
The Oxymag is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company 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 Magnamed Tecnologia Medica S/A manufacture?
Magnamed Tecnologia Medica S/A specializes in the production of ventilatory devices. Currently, the company manufactures the Oxymag, which is a transport and emergency ventilator. This device is specifically designed to provide mechanical ventilation support for patients in critical care settings during transport or acute emergencies.
Where is Magnamed Tecnologia Medica S/A based?
Magnamed Tecnologia Medica S/A is headquartered in the United States. The company’s location in the US may influence regulatory pathways and compliance requirements for its devices.
How are the devices manufactured by Magnamed Tecnologia Medica S/A classified?
The Oxymag ventilator, produced by Magnamed Tecnologia Medica S/A, is classified as a Class II medical device. This classification is determined by regulatory authorities based on factors like the device’s intended use, potential risks, and the level of oversight required to ensure safety and effectiveness.
Which regulatory registries or databases list the devices made by Magnamed Tecnologia Medica S/A?
The Oxymag ventilator is listed under the FDA’s 510(k) pathway, which is a premarket submission required for most Class II devices. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA regulations.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (4)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Oxymag | 1606880 | FDA UDI | Class II | Active |
| Adul/Ped Single Use Accessory Kit For Oxymag | 1709953 | FDA UDI | Class I | Active |
| Kit Disposable Respiratory Circuit | 1707816 | FDA UDI | Class I | Active |
| Oxymag - Transport and Emergency Ventilator | K221634 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Magnamed Tecnologia Medica S/A Sao Paulo · BR FEI 3024290085