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Sign in to claim this brandTraferox Technologies, Inc.
US
Last updated May 23, 2026
What Traferox Technologies, Inc. makes
Traferox Technologies, Inc. develops systems and solutions for preserving and transporting donor lungs, including dedicated preservation solutions and transport systems designed to maintain organ viability during transit. Their portfolio includes both standalone preservation fluids and integrated systems that combine transport containers with the necessary preservation media.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) and UDI pathways. These products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device standards. 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 Traferox Technologies, Inc. manufacture?
Traferox Technologies, Inc. specializes in devices for preserving and transporting donor lungs. Their portfolio includes preservation solutions—fluids designed to maintain organ viability—and transport systems that combine containers with the necessary preservation media. These devices are tailored specifically for lung preservation during transit, ensuring organs remain stable for transplantation.
Where is Traferox Technologies, Inc. based, and how does that affect its regulatory standing?
Traferox Technologies, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the agency’s framework. The FDA’s 510(k) and UDI pathways are used to authorize these Class II devices, ensuring compliance with U.S. medical device standards and transparency in regulatory listings.
Which regulatory registries or databases list Traferox Technologies, Inc.’s devices?
Traferox Technologies, Inc.’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the Unique Device Identifier (UDI) system. These registries confirm that the company’s Class II devices meet U.S. requirements for authorization and traceability, providing clear documentation for healthcare providers and regulators.
How are Traferox Technologies, Inc.’s devices classified under FDA regulations?
Traferox Technologies, Inc.’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The 510(k) pathway is commonly used for these devices to demonstrate substantial equivalence to a legally marketed predicate, ensuring they meet regulatory standards before authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 204279512
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| X°Port Lung Preservation System | 909-0011 | FDA UDI | Class II | Active |
| X°Port Lung Preservation Solution | 910-0003-1L | FDA UDI | Class II | Active |
| X°Port Lung Preservation Solution | 910-0003-2L | FDA UDI | Class II | Active |
| X°Port Lung Preservation Solution | 910-0003-8L-PKG | FDA UDI | Class II | Active |
| LungProtect | K240650 | FDA 510(k) | Class II | Active |
| X°Port Lung Preservation System; X°Port Lung Preservation Solution | K243870 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Traferox Technologies Inc. Mississauga Ontario · CA FEI 3027669473