MeLuna Sport Sapphire Ball Medium Shorty
by MeLuna USA
MeLuna Sport Sapphire Ball Medium Shorty (S-PMB-20) is a Class II device made by MeLuna USA, cleared under FDA 510(k) K140626 on 10 Jul 2014 and listed in FDA GUDID since 17 Nov 2016 (UDI-DI B415SPMB200), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB415SPMB200 | Date17 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140626 | Date10 Jul 2014 | StatusActive |
Official records
- FDA 510(k) database K140626
Across registries
- FDA 510(k) K140626 decided 10 Jul 2014 Active
- FDA GUDID UDI-DI B415SPMB200 listed 17 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K140626
- Listed FDA GUDID B415SPMB200
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MeLuna
- Generic name
- Menstrual cup/disc, non-latex, reusable
- Model / Ref / Catalog
- Sport Sapphire Ball Medium Shorty, S-PMB-20
- Primary DI / UDI-DI
- B415SPMB200
- 510(k) Number
- FDA product code
- HHE
- GMDN term
- Menstrual cup/disc, non-latex, reusable
- Device class
- Class II
- Regulation number
- 884.5400
- GUDID distribution status
- In Commercial Distribution
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