The DivaCup
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during…
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
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 | Diva International, Inc., Canada |
|---|---|
| FDA product code | HHE |
| Device type | Cup, Menstrual |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5400 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K021356 |
| Record published | 2018-02-23 |
| Record revised | 2025-07-14 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case pack of 4, master case of 24, master case box of 60, case pack diva cares of 4, master diva cares of 60, case pack diva cares of 6 |
| Distribution end date | 2022-03-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Model B PL | In distribution | |
| Model A PL | In distribution | |
| Model 0 | In distribution | |
| Model A PL | In distribution | |
| Model 2 | In distribution | |
| Model 1 | In distribution | |
| Model B PL | In distribution | |
| Model B PL | Withdrawn | |
| Model Teen Size | Withdrawn | |
| MT Cup Model A | Withdrawn | |
| MT Cup Model B | Withdrawn | |
| Model A PL | 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 |
| Cora | Cora | 12 |
| myEverCup | Casco BAY Molding | 11 |
| Kind Cup | Wevotopia LLC | 9 |
Showing 12 of 122. All products under Cup, Menstrual
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K021356 | 2002-07-16 |
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.