Meluna
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Meluna makes
Meluna manufactures reusable menstrual cups designed for vaginal insertion to collect menstrual fluid during menstruation. The cups are intended for single-user, reusable applications and come in two variants: Classic and Sport, differentiated by size and material properties.
The company’s products fall under FDA Class II regulatory classification and are authorised via the 510(k) pathway in the United States. The devices are not listed in any additional international registries or databases.
Catalogue
Meluna Classic/Sport Menstrual Cup Ref K140626
Regimes: 510(k) Registry: 510(k)
FDA establishments
- meluna Haundorf Bavaria · DE FEI 3010965020
Frequently asked questions
How many devices does Meluna have in the registry?
The registry currently lists 1 device for Meluna. Devices recorded under merged duplicate company entries are counted once.
Which registries list Meluna's devices?
Among its 1 most recently registered device, Meluna has devices listed in FDA 510(k) (1 device).
What risk classes do Meluna's devices fall under?
Among its 1 most recently registered device, the classes recorded for Meluna's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Meluna in the registry?
The most recently registered devices listed for Meluna include MELUNA CLASSIC/SPORT MENSTRUAL CUP.
Which FDA establishments are linked to Meluna?
1 FDA establishment is linked to Meluna in the registry; they are listed on the company page.