Identity
- Trade Name
- Mamicup® FDA UDI
- Generic Name
- Menstrual cup/disc, non-latex, reusable FDA UDI
- Device Name
- Reusable menstrual cup 100% certified medical grade soft hypoallergenic silicone modern, safe, eco-friendly, economical. Includes: o 1 Mamicup o 1 cotton storage pouch o 1 user instructions Mamicup is the first menstrual cup 100% made in Italy redesigned to collect your menstrual blood naturally and hygienically. Simply fold it, insert it in your vagina and empty it every 4 to 8 hours. Made of certified medical grade soft platinic silicone, it helps avoiding irritations, allergies and inconveniences and lasts up to 5-10 years. It is modern, safe, ecological, economical and makes the period nicer! Suitable also for the night and for sports and travel. Easy to use and clean. FDA UDI
- Model / Reference
- Size M - Pink FDA UDI
- Description
- Reusable menstrual cup 100% certified medical grade soft hypoallergenic silicone modern, safe, eco-friendly, economical. Includes: o 1 Mamicup o 1 cotton storage pouch o 1 user instructions Mamicup is the first menstrual cup 100% made in Italy redesigned to collect your menstrual blood naturally and hygienically. Simply fold it, insert it in your vagina and empty it every 4 to 8 hours. Made of certified medical grade soft platinic silicone, it helps avoiding irritations, allergies and inconveniences and lasts up to 5-10 years. It is modern, safe, ecological, economical and makes the period nicer! Suitable also for the night and for sports and travel. Easy to use and clean. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055349618029 FDA UDI
- FDA Product Code
- HHE FDA UDI
- GMDN Term
- Menstrual cup/disc, non-latex, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Microwave Radiation FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 25 Milliliter FDA UDICircumference — 40 Millimeter FDA UDI
Category: Menstrual cup/disc, non-latex, reusable
Mamicup® by Madalu' Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Madalu' Srl
Sources (1)
- FDA UDI 268aaf0f-f69d-4ebd-8880-3db598efb808 35 fields · synced May 31, 2026