Identity
- Trade Name
- MeLuna FDA UDI
- Generic Name
- Menstrual cup/disc, non-latex, reusable FDA UDI
- Model / Reference
- Sport Sapphire Stem Medium Standard FDA UDI
Identifiers
- Catalog Number
- S-SMS-20 FDA UDI
- Primary DI / UDI-DI
- B415SSMS200 FDA UDI
- 510(k) Number
- K140626 FDA UDI
- FDA Product Code
- HHE FDA UDI
- GMDN Term
- Menstrual cup/disc, non-latex, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Menstrual cup/disc, non-latex, reusable
MeLuna by MeLuna USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K140626 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MeLuna USA
Sources (1)
- FDA UDI 6e52bec7-c5d8-4061-835d-c0b9a0a80fa9 34 fields · synced May 30, 2026