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Sign in to claim this brandWhat Orfit Industries NV makes
Orfit Industries NV manufactures radiological whole-body positioners for precise patient alignment during imaging procedures, as well as head and neck procedure positioners for surgical applications. The company also produces DNA-based tissue typing reagents for in vitro diagnostics and tone audiometers for hearing assessments.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Orfit Industries NV 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 Orfit Industries NV manufacture?
Orfit Industries NV produces a range of medical devices, including radiological whole-body positioners designed to ensure precise patient alignment during imaging, head and neck procedure positioners for surgical use, DNA-based tissue typing reagents for in vitro diagnostics (IVD), and tone audiometers for hearing assessments. These devices serve diverse medical needs, from imaging accuracy to surgical precision and diagnostic testing.
Where is Orfit Industries NV based?
Orfit Industries NV operates from the United States. While the company’s headquarters or primary location isn’t specified, its regulatory presence and device listings confirm its operational base in the country.
Which regulatory registries list Orfit Industries NV’s devices?
Orfit Industries NV’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for each device’s identification, classification, and regulatory status under FDA guidelines.
How are Orfit Industries NV’s devices classified under FDA regulations?
Orfit Industries NV’s devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification depends on the device’s intended use and potential risk level, as outlined in FDA’s regulatory framework.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- orfit.com
- —
- —
- [email protected]
- Phone
- +3233262026
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 283679900
Catalogue (687)
Page 14 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Orfit Industries | 32789 | FDA UDI | Class II | Active |
| Orfit Industries | 32317/5/1 | FDA UDI | Class II | Active |
| Orfit Industries | 33220 | FDA UDI | Class II | Active |
| Orfit Industries | 35791/2MA/NH | FDA UDI | Class II | Active |
| Orfit Industries | 33176 | EUDAMEDFDA UDI | Class II | Active |
| Orfit Industries | 32165/6 | FDA UDI | Class II | Active |
| Orfit Industries | 35779/2MA/NH | FDA UDI | Class II | Active |
| Orfit Industries | 32301/MR | FDA UDI | Class II | Active |
| Orfit Industries | 32046 | FDA UDI | Class II | Active |
| Orfit Industries | 35763/16MI/EM | FDA UDI | Class II | Active |
| Orfit Industries | 32405/10 | FDA UDI | Class II | Active |
| Orfit Industries | 32317/1/HX | FDA UDI | Class II | Active |
| Orfit Industries | 35772/16MI+N | FDA UDI | Class II | Active |
| Orfit Industries | 29053 | FDA UDI | Class II | Active |
| Orfit Industries | 32301-PED/MR | FDA UDI | Class II | Active |
| Orfit Industries | 35713-MD | FDA UDI | Class II | Active |
| Orfit Industries | 35772/16MI | FDA UDI | Class II | Active |
| Orfit Industries | 33739/2MA/12MI+N | FDA UDI | Class II | Active |
| Orfit Industries | 35768/2MA/NP | FDA UDI | Class II | Active |
| Orfit Industries | 32412 | FDA UDI | Class II | Active |
| Orfit Industries | 32151 | FDA UDI | Class II | Active |
| Orfit Industries | 32379 | FDA UDI | Class II | Active |
| Orfit Industries | 32172 | FDA UDI | Class II | Active |
| Orfit Industries | 32048 | FDA UDI | Class II | Active |
| Orfit Industries | 60110 | FDA UDI | Class II | Active |
| Orfit Industries | 32127 | FDA UDI | Class II | Active |
| Orfit Industries | 32001 | FDA UDI | Class II | Active |
| Orfit Industries | 33688/2MA | FDA UDI | Class II | Active |
| Orfit Industries | 32015/9/3 | FDA UDI | Class II | Active |
| Raycast High Precision Lung Board Solution | K162862 | FDA 510(k) | Class II | Active |
| Sagittilt | K141787 | FDA 510(k) | Class II | Active |
| Proton Immobilization Solution | K151207 | FDA 510(k) | Class II | Active |
| The AIO Solution 3.0 | K202068 | EUDAMEDFDA 510(k) | Class II | Active |
| Raycast MammoRx Carbon Fibre Breast Board | K162355 | FDA 510(k) | Class II | Active |
| HP PRO Positioning Device | K171734 | FDA 510(k) | Class II | Active |
| Orfit Aerial Couchtop | K200282 | FDA 510(k) | Class II | Active |
| Nanor And Efficast/Nanor Hybrid Thermoplastic Materials | K131795 | FDA 510(k) | Class II | Active |
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