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Sign in to claim this brandWhat DX PRODUCTS LIMITED makes
DX Products Limited manufactures penile vacuum devices designed for medical and personal use, including models like the Bathmate and Vaxaid. These devices are intended for use in clinical and home settings to address vascular-related conditions or enhance blood flow.
The company’s products are classified as Class II devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. DX Products Limited 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 DX Products Limited manufacture?
DX Products Limited specializes in penile vacuum devices, which are designed to improve blood flow in the penis. These devices are used in both clinical and home settings to address vascular-related conditions. Examples of their products include the Bathmate and Vaxaid series.
Where is DX Products Limited based?
DX Products Limited is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.
How are DX Products Limited’s devices classified under FDA regulations?
DX Products Limited’s penile vacuum devices fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Are DX Products Limited’s devices listed in any regulatory databases?
Yes, DX Products Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency in the supply chain, helping regulators and healthcare providers verify product authenticity and compliance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bathmatedirect.com
- —
- —
- [email protected]
- Phone
- +1-844-900-0555
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 216732051
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bathmate | Hydro 5 Crystal Clear | FDA UDI | Class II | Active |
| Vaxaid | Vaxaid V5 Trainer | FDA UDI | Class II | Active |
| Bathmate | Xersizer 5 | FDA UDI | Class II | Active |
| Bathmate | Hydro 5 Aqua Blue | FDA UDI | Class II | Active |
| Bathmate | Hydro 3 Crystal Clear | FDA UDI | Class II | Active |
| Bathmate | Hydro 5 Brilliant Red | FDA UDI | Class II | Active |
| Bathmate | Hydro 3 Brilliant Red | FDA UDI | Class II | Active |
| Bathmate | Hydro 3 Aqua Blue | FDA UDI | Class II | Active |
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