Mamicup®

Basic Information

• Brand Name: Mamicup®
• Primary DI: 08055349618005
• Version / Model: Size M - Transparent
• Company Name: MADALU' SRL
• Labeler DUNS: 440514105
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-15
• Public Version: 3
• Public Version Date: 2025-07-14
• Public Version Status: Update
• Public Device Record Key: 7ba1cb0a-12f4-4bb1-a4ca-35b596dead53

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Microwave Radiation

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HHE	Cup, Menstrual	Obstetrics/Gynecology	884.5400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47728	Menstrual cup/disc, non-latex, reusable	A cup-like or disc-shaped receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is typically removed from the vagina by pulling on a protruding stem/ring or by insertion of a finger to catch its rim. The device can function as an alternative to tampons and may remain in situ during sexual intercourse. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18055349618002	GS1		6	In Commercial Distribution
Primary	08055349618005	GS1
Package	28055349618009	GS1		10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	25	Milliliter
Circumference	40	Millimeter