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Sign in to claim this brandAxial Medical Printing Limited
US
Last updated May 31, 2026
What Axial Medical Printing Limited makes
Axial Medical Printing Limited produces custom-made anatomical models of organs and bones, designed for surgical planning and educational purposes. Their offerings include cloud-based segmentation services and software tools that generate detailed 3D representations from medical imaging data.
These products are classified as Class II medical devices and are authorised via FDA 510(k) clearances and listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Axial Medical Printing Limited manufacture?
Axial Medical Printing Limited specializes in custom-made anatomical models of organs and bones. These models are primarily created for surgical planning and educational use. Their products include cloud-based segmentation services and software tools, such as the Axial3D Cloud Segmentation Service and Axial3D Insight, which generate detailed 3D anatomical representations from medical imaging data.
Where is Axial Medical Printing Limited based?
Axial Medical Printing Limited is based in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in relation to FDA requirements for its devices.
Which regulatory registries or databases list Axial Medical Printing Limited’s devices?
Axial Medical Printing Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database and are authorised through FDA 510(k) clearances. These registries ensure traceability and compliance with U.S. medical device regulations, helping healthcare providers verify the legitimacy and classification of the products.
How are Axial Medical Printing Limited’s devices classified under medical device regulations?
Axial Medical Printing Limited’s devices are classified as Class II medical devices. This classification is determined by the FDA based on factors like the intended use and potential risk to patients. Class II devices generally require special controls in addition to general controls to ensure safety and effectiveness, and they are authorised through the 510(k) premarket notification process.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- axial3d.com
- —
- —
- [email protected]
- Phone
- +4402890183590
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 219447389
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Axial3D Cloud Segmentation Service | 1 | FDA UDI | Class II | Active |
| Axial3D Insight | K222745 | FDA 510(k) | Class II | Active |
| Axial3D Cloud Segmentation Service | K221511 | FDA 510(k) | Class II | Active |
| Axial3D Insight | K232841 | FDA 510(k) | Class II | Active |
| Axial3D Cloud Segmentation Service | K231607 | FDA 510(k) | Class II | Active |
| Axial3D Insight | K250369 | EUDAMEDFDA 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.
- Axial Medical Printing Limited Belfast · GB FEI 3016824824