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US
Last updated May 23, 2026
What SOULE CO., THE makes
The company manufactures freestanding patient positioners and headrests designed for single-use and reusable applications. These devices are intended to support and position patients during medical procedures, including those in radiology, surgery, and diagnostic imaging.
All listed devices fall under Class I classification in the FDA’s UDI system. The products are registered under the FDA’s Unique Device Identifier (UDI) program, ensuring traceability and compliance with regulatory requirements. 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 Soule Co., The manufacture?
Soule Co., The manufactures freestanding patient positioners and headrests. These devices are designed for single-use or reusable applications and are intended to support and position patients during medical procedures such as radiology, surgery, and diagnostic imaging. The company specializes in equipment that aids in patient stability and comfort during clinical interventions.
Where is Soule Co., The based?
Soule Co., The is based in the United States. The company’s location aligns with its focus on manufacturing medical devices that comply with U.S. regulatory standards, including the FDA’s Unique Device Identifier (UDI) program.
Are Soule Co., The’s devices listed in any regulatory registries?
Yes, Soule Co., The’s devices are listed in the FDA’s Unique Device Identifier (UDI) system. This registry ensures traceability and compliance with regulatory requirements, allowing for clear identification and tracking of the company’s Class I medical devices.
How are Soule Co., The’s devices classified by regulatory authorities?
Soule Co., The’s devices fall under Class I classification in the FDA’s UDI system. Class I devices are generally considered to pose the lowest risk and typically do not require pre-market approval, though they still must meet regulatory standards for safety and performance.
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
- 032801706
Catalogue (226)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Soule Medical | HR104-CC | FDA UDI | Class I | Active |
| Soule Medical | WF1000 | FDA UDI | Class I | Active |
| Soule Medical | CP602S | FDA UDI | Class I | Active |
| Soule Medical | BCTS | FDA UDI | Class I | Active |
| Soule Medical | JT1000DCP-PFC | FDA UDI | Class I | Active |
| Soule Medical | AKH102 | FDA UDI | Class I | Active |
| Soule Medical | BOL102 | FDA UDI | Class I | Active |
| Soule Medical | SOWS-CC | FDA UDI | Class I | Active |
| Soule Medical | PBBP-9 | FDA UDI | Class I | Active |
| Soule Medical | BBP3040G | FDA UDI | Class I | Active |
| Soule Medical | RG2655 | FDA UDI | Class I | Active |
| Soule Medical | WD262712 | FDA UDI | Class I | Active |
| Soule Medical | PFXH1000 | FDA UDI | Class I | Active |
| Soule Medical | SRUEWL-CC | FDA UDI | Class I | Active |
| Soule Medical | APG202 | FDA UDI | Class I | Active |
| Soule Medical | ABS01 | FDA UDI | Class I | Active |
| Soule Medical | WD22129-CC | FDA UDI | Class I | Active |
| Soule Medical | BBP1020G | FDA UDI | Class I | Active |
| Soule Medical | CCDC-100 | FDA UDI | Class I | Active |
| Soule Medical | BBP1020 | FDA UDI | Class I | Active |
| Soule Medical | RG2130 | FDA UDI | Class I | Active |
| Soule Medical | WF1002 | FDA UDI | Class I | Active |
| Soule Medical | HR105 | FDA UDI | Class I | Active |
| Soule Medical | SULT-CC | FDA UDI | Class I | Active |
| Soule Medical | HR101N | FDA UDI | Class I | Active |
| Soule Medical | BOL101 | FDA UDI | Class I | Active |
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