EllaCup
A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small,…
A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.
Who Else Makes It
Concentrated in Guangdong (8), Zhejiang (4), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Fansheng Technology (Guangdong) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 8 |
| Suzhou Armocon Technology Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Ningbo Hanyue Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 27 |
| Quanzhou V-Care Sanitary Products Co., Ltd. | Quanzhou | Fujian | Manufacturer | 10 |
| Shandong Hengfa Hygienic Products Co., Ltd. | Linqing City,Liaocheng | Shandong | Manufacturer | 10 |
| Dongguan Sheng Yan Industrial Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Shenzhen S-Hande Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
Showing 12 of 20. All 20 manufacturers in China registered for Cup, Menstrual
Record
| Listed by | Mieux LLC |
|---|---|
| FDA product code | HHE |
| Device type | Cup, Menstrual |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5400 |
| Premarket notification | Exempt |
| Record published | 2016-05-04 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Distribution end date | 2017-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MeLuna | MeLuna USA | 144 |
| Pixie Cup | Pixie CUP LLC | 25 |
| Casco Cup | Casco BAY Molding | 24 |
| MonthlyCup | Monthlycup AB | 21 |
| AneerCare | Dongguan Aimei Silicone Products Co., Ltd. | 19 |
| Saalt Menstrual Cup | Saalt, LLC | 18 |
| Flex | The Flex Company | 18 |
| Lena | Lena Cup | 16 |
| Hello Period | THE Hello CUP | 15 |
| The DivaCup | Diva International, Inc. | 12 |
| Cora | Cora | 12 |
| myEverCup | Casco BAY Molding | 11 |
Showing 12 of 122. All products under Cup, Menstrual
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.