{"publicDeviceRecordKey":"7ba1cb0a-12f4-4bb1-a4ca-35b596dead53","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-07-14T00:00:00.000Z","devicePublishDate":"2020-04-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"18055349618002","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08055349618005","pkgQuantity":6,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"08055349618005","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"28055349618009","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08055349618005","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null}]},"brandName":"Mamicup®","versionModelNumber":"Size M - Transparent","catalogNumber":null,"dunsNumber":"440514105","companyName":"MADALU' SRL","deviceCount":1,"deviceDescription":"Reusable menstrual cup  100% certified medical grade soft hypoallergenic silicone modern, safe, eco-friendly, economical.\nIncludes:\no\t1 Mamicup\no\t1 cotton storage pouch\no\t1 user instructions\nMamicup 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.\nIt 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. \n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+39 0431341567","phoneExtension":null,"email":"info@coppetta-mestruale.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47728","gmdnPTName":"Menstrual cup/disc, non-latex, reusable","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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HHE","productCodeName":"Cup, Menstrual"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Total Volume","size":{"unit":"Milliliter","value":"25"},"sizeText":null,"sizeString":"Total Volume: 25 Milliliter"},{"sizeType":"Circumference","size":{"unit":"Millimeter","value":"40"},"sizeText":null,"sizeString":"Circumference: 40 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Microwave Radiation"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}