Flex

Box of Flex Disc 12 count (Direct-to-Consumer)

Registry build 21.09.26
20manufacturers in China registered for this device type
18catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code HHE
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

Regulatory record for Flex
Listed by The Flex Company, United States
FDA product code HHE
Device type Cup, Menstrual
Device class Class 2
Regulation 21 CFR 884.5400
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-09-06
Record revised 2025-07-14 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Packaging Master case of 6, case of 6, case of 24, pack of 20, pack of 3, pack of 2

Catalogue Numbers

Catalogue numbers for Flex
Catalogue number Size Per pack Status
10150 24 In distribution
10035 16 In distribution
Box of Flex 12 count (English only) VERTICAL 12 In distribution
Flex 8 count bag (English only) 8 In distribution
Box of Flex Disc 8 ct. 8 In distribution
Box of Flex 16 count (English only) 24 In distribution
Flex 24 count bag (English only) 24 In distribution
Flex 16 count bag (English only) 16 In distribution
10268 2 In distribution
Box of Flex 8 count (English only) 8 In distribution
10255 6 In distribution
10260 24 In distribution
Box of Flex 24 count (English only) 24 In distribution
10017 8 In distribution
Box of Flex 10 count (English only) 10 In distribution
Flex Chamfer Disc 101 (IHUT) 8 In distribution
Box of Flex 12 count (English only) 12 In distribution
Flex Disc 102 (IHUT) 8 In distribution

Same Product Code

Other products under the same FDA 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
Lena Lena Cup 16
Hello Period THE Hello CUP 15
The DivaCup Diva International, Inc. 12
Cora Cora 12
myEverCup Casco BAY Molding 11
Kind Cup Wevotopia LLC 9

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer