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Sign in to claim this brandMADALU' SRL
US
Last updated May 24, 2026
What MADALU' SRL makes
The company produces reusable menstrual cups and discs made from non-latex materials, designed for internal use during menstruation. These products are intended for single-user, long-term use and are marketed as an alternative to disposable menstrual products.
The portfolio is classified as Class II medical devices under FDA regulations and is listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer 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 Madalu’ SRL manufacture?
Madalu’ SRL specializes in reusable menstrual cups and discs made from non-latex materials. These devices are designed for internal use during menstruation and are intended to replace disposable menstrual products. The company focuses exclusively on this category of Class II medical devices.
Where is Madalu’ SRL based, and does it operate internationally?
Madalu’ SRL is based in the United States. While the company’s headquarters and primary operations are located there, the specific details about international distribution or manufacturing facilities are not provided in the available data.
How are Madalu’ SRL’s devices classified under FDA regulations?
Madalu’ SRL’s menstrual cups and discs fall under Class II medical device classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as sterilization validation or performance standards.
Are Madalu’ SRL’s devices listed in any regulatory registries?
Yes, Madalu’ SRL’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing for better monitoring of device performance and compliance with regulatory requirements.
What materials are used in Madalu’ SRL’s menstrual cups and discs?
Madalu’ SRL’s menstrual cups and discs are made from non-latex materials, which helps reduce the risk of allergic reactions for users. The reusable nature of these products is also highlighted as a key feature, distinguishing them from single-use alternatives.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- coppetta-mestruale.com
- —
- —
- [email protected]
- Phone
- +39 0431341567
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 440514105
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mamicup® | Size L - Pink | FDA UDI | Class II | Active |
| Mamicup® | Size M - TURQUOISE | FDA UDI | Class II | Active |
| Mamicup® | Size M - Lilac | FDA UDI | Class II | Active |
| Mamicup® | Size L - Lilac | FDA UDI | Class II | Active |
| Mamicup® | Size L - TURQUOISE | FDA UDI | Class II | Active |
| Mamicup® | Size L - Transparent | FDA UDI | Class II | Active |
| Mamicup® | Size M - Pink | FDA UDI | Class II | Active |
| Mamicup® | Size M - Transparent | FDA UDI | Class II | Active |
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