<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>7ba1cb0a-12f4-4bb1-a4ca-35b596dead53</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2025-07-14</publicVersionDate><devicePublishDate>2020-04-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>18055349618002</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08055349618005</containsDINumber><pkgQuantity>6</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>08055349618005</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier><identifier><deviceId>28055349618009</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08055349618005</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Mamicup®</brandName><versionModelNumber>Size M - Transparent</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>440514105</dunsNumber><companyName>MADALU&apos; SRL</companyName><deviceCount>1</deviceCount><deviceDescription>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. 
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+39 0431341567</phone><phoneExtension xsi:nil="true"/><email>info@coppetta-mestruale.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>47728</gmdnCode><gmdnPTName>Menstrual cup/disc, non-latex, reusable</gmdnPTName><gmdnPTDefinition>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.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HHE</productCode><productCodeName>Cup, Menstrual</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Total Volume</sizeType><size unit="Milliliter" value="25"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Circumference</sizeType><size unit="Millimeter" value="40"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Microwave Radiation</sterilizationMethod></methodTypes></sterilization></device>