External Urethral Occluder, Urinary Incontinence-Control, Female
Who Makes This Device Type in China?
3 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Zhejiang.
- Guangdong Bingbing Health Care Products Ltd. Guangdong
- Huzhou Universal Glove Company Limited Zhejiang
- Yearstar Healthcare Technology Co., Ltd. Jiangsu, contract manufacturer
What Is It?
Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad.
May include adhesive gel or ointment.
What Is FDA Product Code MNG?
External Urethral Occluder, Urinary Incontinence-Control, Female is FDA product code MNG, Class 1, 21 CFR 876.5160.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
Name
Record