Identity
- Trade Name
- MCUK Menstrual Cup Size A FDA UDI
- Generic Name
- Menstrual cup/disc, non-latex, reusable FDA UDI
- Device Name
- A menstrual cup is a receptacle placed in the vagina to collect menstrual flow. FDA UDI
- Model / Reference
- Size A FDA UDI
- Description
- A menstrual cup is a receptacle placed in the vagina to collect menstrual flow. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060053021129 FDA UDI
- 510(k) Number
- K060852 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
MCUK Menstrual Cup Size A by Mooncup, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Menstrual cup/disc, non-latex, reusable.
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- Intimina Lily Cup Size B - EN — Leloi AB · Class II
- Oi — ORGANIC INITIATIVE CORPORATION · Class II
- MeLuna — MeLuna USA · Class II
- LEONA — LOON LAB INC. · Class II
Cleared under the same submission
K060852 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
- Mooncup, LLC
Sources (1)
- FDA UDI f9d6a427-1eeb-4090-87fa-ef5c96972f91 35 fields · synced Jun 1, 2026