FDA.reportPublic FDA data

Mamicup®

Primary DI
08055349618029
Brand
Mamicup®
Company
MADALU' SRL
Model
Size M - Pink
Device description
Reusable menstrual cup 100% certified medical grade soft hypoallergenic silicone modern, safe, eco-friendly, economical.Includes:o 1 Mamicupo 1 cotton storage poucho 1 user instructionsMamicup 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.
Published
2020-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHECup, Menstrual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHECup, MenstrualObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18055349618026PackageGS16In Commercial Distribution
28055349618023PackageGS110In Commercial Distribution
08055349618029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805534961802618055349618026
2805534961802328055349618023
08055349618029080553496180298055349618029

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual cup/disc, non-latex, reusableA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference40Millimeter
Total Volume25Milliliter

Sterilization Methods#

Method table
Method
Microwave Radiation

Contacts#

Phone, Email table
PhoneEmail
+39 0431341567info@coppetta-mestruale.com

Regulatory Flags#

DUNS number
440514105
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055349618005Mamicup®Size M - Transparent2020-04-15
08055349618012Mamicup®Size L - Transparent2020-04-15
08055349618036Mamicup®Size L - Pink2020-04-15
08055349618043Mamicup®Size M - TURQUOISE2020-04-15
08055349618050Mamicup®Size L - TURQUOISE2020-04-15
08055349618067Mamicup®Size M - Lilac2020-04-15
08055349618074Mamicup®Size L - Lilac2020-04-15
18055349618002Mamicup®Size M - Transparent2020-04-15
18055349618019Mamicup®Size L - Transparent2020-04-15
18055349618026Mamicup®Size M - Pink2020-04-15
18055349618033Mamicup®Size L - Pink2020-04-15
18055349618040Mamicup®Size M - TURQUOISE2020-04-15
18055349618057Mamicup®Size L - TURQUOISE2020-04-15
18055349618064Mamicup®Size M - Lilac2020-04-15
18055349618071Mamicup®Size L - Lilac2020-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860012792801LunableYayoi FemTech Inc.HHE2025-09-02
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00841445001333DivaCup ImpactDiva International IncHHE2025-09-01
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00850016867780Pixie CupPixie Cup LLCHHE2025-06-24
00860013832001Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832018Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00860013832025Selaviera CupCASCO BAY MOLDING LTD.HHE2025-06-18
00850037498420FlexThe Flex CompanyHHE2025-06-12
10850037498427FlexThe Flex CompanyHHE2025-06-12
09421907199696Hello PeriodTHE HELLO CUP COMPANY LIMITEDHHE2025-06-10
07898976999007Mestrual disc clear SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999014Mestrual disc clear MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999021Mestrual disc clear HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999038Mestrual disc Pink Love SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999045Mestrual disc Pink Love MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999052Mestrual disc Pink Love HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999069Mestrual disc Unicorn SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999076Mestrual disc Unicorn MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999083Mestrual disc Unicorn HighINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999090Mestrual cup Pink Love SmallINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09
07898976999106Mestrual cup Pink Love MediumINJEMEDIC MATERIAL MEDICO E HOSPITALAR LTDAHHE2025-06-09