Identity
- Trade Name
- Lena FDA UDI
- Generic Name
- Menstrual cup/disc, non-latex, reusable FDA UDI
- Device Name
- A reusable menstrual cup that collects monthly blood flow. FDA UDI
- Model / Reference
- LENA-PUR-L FDA UDI
- Description
- A reusable menstrual cup that collects monthly blood flow. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850008236068 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 45 Millimeter FDA UDILength — 70.5 Millimeter FDA UDITotal Volume — 30 Milliliter FDA UDI
Category: Menstrual cup/disc, non-latex, reusable
Lena by Lena Cup — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Menstrual cup/disc, non-latex, reusable.
- MeLuna — MeLuna USA · Class II
- MeLuna — MeLuna USA · Class II
- COTTON HIGH TECH SL — COTTON HIGH TECH SL · Class II
- Angelcup - Lilac — Grupo IX Kaan, S.A. de C.V. · Class II
- 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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lena Cup
Sources (1)
- FDA UDI 28870ab6-e611-4e11-bac9-76beb4cac3d7 35 fields · synced Jun 1, 2026