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Sign in to claim this brandLUWI, LLC
US
Last updated May 25, 2026
What LUWI, LLC makes
LUWI, LLC manufactures silicone-based sexual lubricants, including a 2oz premium formula and a 5mL travel-sized variant designed for convenience. These products are formulated for use in intimate health applications and are marketed in single-use and multi-use packaging.
The company’s lubricants are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The products are intended for distribution 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 LUWI, LLC manufacture?
LUWI, LLC specializes in silicone-based sexual lubricants. Their primary product category is sexual lubricants, including a premium 2oz formula and a smaller 5mL travel-sized variant. These products are designed for intimate health applications and are available in both single-use and multi-use packaging.
Where is LUWI, LLC based, and where are their devices intended for distribution?
LUWI, LLC is based in the United States. Their devices are specifically formulated and intended for distribution within the U.S. market.
How are LUWI’s devices classified under FDA regulations?
LUWI’s lubricants are classified as Class II medical devices 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 labeling requirements or performance standards.
Are LUWI’s devices listed in any regulatory registries?
Yes, LUWI’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes.
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
- —
- DUNS Number
- 034357900
Catalogue (3)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Luwi | 4LUWI | FDA UDI | Class II | Unknown |
| LUWI - LUWI Lube Premium Silicone - 2oz | LL2OZSBTL | FDA UDI | Class II | Active |
| LUWI - LUWI Lube Littles Premium Silicone - 5mL | LL5ML1QTY | FDA UDI | Class II | Active |
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