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Sign in to claim this brandMeLuna USA
US
Last updated May 25, 2026
What MeLuna USA makes
The company produces reusable menstrual cups and discs made from non-latex materials, designed for menstrual hygiene management. These products are intended for vaginal insertion to collect menstrual flow during menstruation.
The portfolio is classified as Class II medical devices and is 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 MeLuna USA manufacture?
MeLuna USA specializes in reusable menstrual cups and discs made from non-latex materials. These devices are designed for vaginal insertion to collect menstrual flow during menstruation, providing a sustainable alternative to disposable menstrual products.
Where is MeLuna USA based, and what does this mean for regulatory oversight?
MeLuna USA is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s Unique Device Identifier (UDI) database includes MeLuna’s products, which helps ensure traceability and compliance with U.S. medical device requirements.
How are MeLuna’s devices classified by regulatory authorities?
MeLuna’s menstrual cups and discs are classified as Class II medical devices. This classification typically means they pose moderate risks and require special controls beyond general good manufacturing practices to ensure safety and effectiveness, as determined by regulatory standards.
Which regulatory registries or databases list MeLuna’s products?
MeLuna’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This database helps track and identify medical devices in the U.S. market, ensuring transparency and compliance with regulatory requirements for traceability.
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
- 026952939
Catalogue (144)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MeLuna | Classic Sapphire Ball Large Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Ball Large Standard | FDA UDI | Class II | Active |
| MeLuna | Sport Clear Stem X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Ball Medium Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Ball Small Standard | FDA UDI | Class II | Active |
| MeLuna | Sport Amethyst Ring Small Standard | FDA UDI | Class II | Active |
| MeLuna | Sport Amethyst Stem X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Clear Ring X-Large Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Ball X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Amethyst Stem Medium Standard | FDA UDI | Class II | Active |
| MeLuna | Sport Sapphire Ball X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Clear Ball Medium Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Stem Medium Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Clear Ball Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Ring Medium Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Ring X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Sapphire Ring Small Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Clear Stem Medium Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Sapphire Ring Medium Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Sapphire Stem Medium Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Sapphire Ball Medium Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Ring X-Large Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Stem Large Standard | FDA UDI | Class II | Active |
| MeLuna | Sport Amethyst Ring X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Ball Medium Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Ring Large Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Ball Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Amethyst Ring Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Ball Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Stem Small Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Stem Small Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Clear Ring Large Standard | FDA UDI | Class II | Active |
| MeLuna | Sport Sapphire Stem Medium Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Clear Ball X-Large Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Stem Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Stem X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Clear Ring X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Sapphire Stem X-Large Standard | FDA UDI | Class II | Active |
| MeLuna | Sport Sapphire Ring Medium Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Stem Large Standard | FDA UDI | Class II | Active |
| MeLuna | Sport Sapphire Stem Large Standard | FDA UDI | Class II | Active |
| MeLuna | Sport Amethyst Ring X-Large Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Amethyst Stem X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Clear Ball X-Large Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Clear Ball Medium Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Ring Small Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Stem X-Large Standard | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Ring Small Shorty | FDA UDI | Class II | Active |
| MeLuna | Sport Amethyst Ball X-Large Shorty | FDA UDI | Class II | Active |
| MeLuna | Classic Sapphire Ball X-Large Standard | FDA UDI | Class II | Active |
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