Within the United States, a Menstrual Cup is categorized as a short-term implantable medical device.
To be sold legally in the USA, a Menstrual Cup needs to be registered.
The manufacturer of the Menstrual Cup must also be registered.
Being registered with the FDA does NOT mean that a cup was tested or approved by the FDA.
Having an FDA registration ensures that IF something should go wrong such as a defective batch or contaminated batch, the FDA has contact information for the vendor/manufacturer if a recall needs to be made.