FDA.reportPublic FDA data

Mamicup®

Primary DI
18055349618064
Brand
Mamicup®
Company
MADALU' SRL
Model
Size M - Lilac
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.
Published
2020-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
18055349618064PackageGS16In Commercial Distribution
28055349618061PackageGS110In Commercial Distribution
08055349618067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805534961806418055349618064
2805534961806128055349618061
08055349618067080553496180678055349618067

GMDN Terms#

Term, Definition table
TermDefinition
Menstrual cup, non-latex, reusableA cup-like 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 normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
08055349618029Mamicup®Size M - Pink2020-04-15
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
18055349618071Mamicup®Size L - Lilac2020-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00860012792801LunableYayoi FemTech Inc.HHE2025-09-02
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00715875074840Pixie CupPixie Cup LLCHHE2025-06-25
00850016867742Pixie CupPixie Cup LLCHHE2025-06-25
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