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Sign in to claim this brandMooncup, LLC
US
Last updated May 23, 2026
What Mooncup, LLC makes
Mooncup, LLC manufactures reusable menstrual cups and discs made from non-latex materials. These products are designed for menstrual hygiene, offering a flexible, silicone-based alternative to disposable options. The portfolio includes multiple sizes and styles, including the MCUK Menstrual Cup (sizes A and B) and the MOONCUP in styles A and B.
The company’s products fall under FDA Class II regulation and are listed via 510(k) clearance and the FDA’s Unique Device Identifier (UDI) system. The devices are authorised for use 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 Mooncup, LLC manufacture?
Mooncup, LLC specialises in reusable menstrual cups and discs made from non-latex materials. These devices are designed for menstrual hygiene and serve as an alternative to single-use products. The company’s portfolio includes multiple sizes and styles, such as the MCUK Menstrual Cup (available in sizes A and B) and the MOONCUP in styles A and B, all made from silicone.
Where is Mooncup, LLC based?
Mooncup, LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries or databases list Mooncup, LLC’s devices?
Mooncup, LLC’s devices are listed in the FDA’s 510(k) clearance registry and the FDA’s Unique Device Identifier (UDI) system. These registries are used to track and authorise medical devices in the United States, ensuring compliance with regulatory requirements.
How are Mooncup, LLC’s devices classified by regulatory authorities?
Mooncup, LLC’s menstrual cups and discs are classified as FDA Class II devices. This classification is based on the level of risk associated with the product, where Class II devices require special controls in addition to general controls to ensure their safety and effectiveness. The company’s devices are authorised for use in the US under this classification.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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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
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Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MCUK Menstrual Cup Size B (NP) | Size B | FDA UDI | Class II | Active |
| MCUK Menstrual Cup Size B | Size B | FDA UDI | Class II | Active |
| MCUK Menstrual Cup Size A | Size A | FDA UDI | Class II | Active |
| Mooncup | K060852 | FDA 510(k) | Class II | Active |
| Mooncup, Style A & B | K040335 | FDA 510(k) | Class II | Active |
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