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Sign in to claim this brandMir Medical International Research USA
US
Last updated May 23, 2026
What Mir Medical International Research USA makes
Mir Medical International Research USA manufactures the Spirobank Oxi, a portable device designed for measuring respiratory function, including spirometry and oxygen saturation levels.
The Spirobank Oxi 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 Mir Medical International Research USA manufacture?
Mir Medical International Research USA specializes in respiratory measurement devices. Their primary product, the Spirobank Oxi, is a portable device used for assessing respiratory function, including spirometry and oxygen saturation monitoring. This device combines multiple diagnostic capabilities into a single handheld unit, making it suitable for both clinical and home-use settings.
Where is Mir Medical International Research USA based, and does this affect its regulatory standing?
Mir Medical International Research USA is headquartered in the United States. The company’s location influences its regulatory obligations, as it must comply with U.S. medical device regulations, including those governed by the FDA. However, regulatory standing is determined by individual devices, not the company itself, and depends on their classification and compliance with applicable requirements.
How are the devices manufactured by Mir Medical International Research USA classified under U.S. regulations?
The Spirobank Oxi, Mir Medical International Research USA’s example device, is classified as a Class II medical device under U.S. regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness. Due to its classification, the device is subject to the FDA’s 510(k) premarket notification process, where the manufacturer must demonstrate that it is substantially equivalent to a legally marketed predicate device.
Which regulatory registries or databases list devices from Mir Medical International Research USA?
Mir Medical International Research USA’s devices, such as the Spirobank Oxi, are listed under the FDA’s 510(k) pathway, meaning they have undergone the required premarket notification process to demonstrate compliance with U.S. regulations. While the company itself isn’t listed in registries, its devices appear in databases like the FDA’s 510(k) Premarket Notification Database when they are cleared for market. This ensures transparency about their regulatory status and intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (45)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mir | MIR SPIRODOC OXIMETER | EUDAMEDFDA UDI | Class II | Active |
| Mir | Spirobank II PLUS | FDA UDI | Class II | Active |
| Mir | MIR SPIROTEL SPIROMETER | FDA UDI | Class II | Active |
| Mir | MIR Spirobank II New BLE spirometer | EUDAMEDFDA UDI | Class II | Active |
| Mir | MiniSpir PLUS | FDA UDI | Class II | Active |
| Mir | Smart One USA | FDA UDI | Class II | Active |
| Mir | Spirobank Oxi | FDA UDI | Class II | Active |
| Mir | Spirobank II Light | FDA UDI | Class II | Active |
| Mir | MiniSpir spirometer | FDA UDI | Class II | Active |
| Mir | Spirolab PLUS | FDA UDI | Class II | Active |
| Mir | MiniSpir spirometer with cable | EUDAMEDFDA UDI | Class II | Active |
| Mir | MIR SPIROTEL SPIROMETER WITH OXIMETRY | FDA UDI | Class II | Active |
| Mir | Spirobank II PLUS | FDA UDI | Class II | Active |
| Mir | MIR SPIROBANK SMART | FDA UDI | Class II | Active |
| Mir | MIR Spirobank II New spirometer | FDA UDI | Class II | Active |
| Mir | Spirolab New spirometer | EUDAMEDFDA UDI | Class II | Active |
| Mir | MIR SPIROTEL SPIROMETER WITH BLUETOOTH | FDA UDI | Class II | Active |
| Mir | MiniSpir spirometer Light POST BD Edition | FDA UDI | Class II | Active |
| Mir | MIR Spirobank II New spirometer and oximeter | FDA UDI | Class II | Active |
| Mir | FlowMIR | EUDAMEDFDA UDI | Class I | Active |
| Mir | MIR Spirobank II New BLE spiro & oxy | EUDAMEDFDA UDI | Class II | Active |
| Mir | MIR SPIRODOC SPIROMETER AND OXIMETER | EUDAMEDFDA UDI | Class II | Active |
| Mir | Spirolab PLUS | FDA UDI | Class II | Active |
| Mir | MiniSpir PLUS | FDA UDI | Class II | Active |
| Mir | MIR Spirobank II New Basic | FDA UDI | Class II | Active |
| Mir | Spirolab New spirometer + oximeter | EUDAMEDFDA UDI | Class II | Active |
| Cohero | cSpirometer | EUDAMEDFDA UDI | Class II | Active |
| Mir | FlowMIR | EUDAMEDFDA UDI | Class I | Active |
| Mir | Spirolab PLUS | FDA UDI | Class II | Active |
| Mir | Spirolab PLUS | FDA UDI | Class II | Active |
| Mir | AsthmaTuner | FDA UDI | Class II | Active |
| Mir | MIR SPIROTEL SPIROMETER BASIC | FDA UDI | Class II | Active |
| Mir | Spirolab New spirometer Light Bluetooth | FDA UDI | Class II | Active |
| Mir | Spirobank II PLUS | FDA UDI | Class II | Active |
| Mir | MIR Spirobank II New Basic | EUDAMEDFDA UDI | Class II | Active |
| Mir | MIR Spirobank II New spirometer and oximeter | FDA UDI | Class II | Active |
| Mir | Spirobank II Light | FDA UDI | Class II | Active |
| Mir | Nuvoair | EUDAMEDFDA UDI | Class I | Active |
| Cohero | mSpirometer | EUDAMEDFDA UDI | Class II | Active |
| Mir | Spirobank II PLUS | FDA UDI | Class II | Active |
| Mir | Smart One Oxi | EUDAMEDFDA UDI | Class II | Active |
| Mir | Spirolab New spirometer Light | FDA UDI | Class II | Active |
| Smart One | K181666 | FDA 510(k) | Class II | Active |
| Spirodoc | K103530 | FDA 510(k) | Class II | Active |
| Spirobank Oxi | K230501 | FDA 510(k) | Class II | Active |
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