Data / Medical devices / External Urethral Occluder, Urinary Incontinence-Control, Female
External Urethral Occluder, Urinary Incontinence-Control, Female (MNG): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make External Urethral Occluder, Urinary Incontinence-Control, Female (product code MNG, Class 1, 21 CFR 876.5160). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on April 30, 2001, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MNG
- Device class
- 1
- Regulation
- 876.5160
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| Mexico | 1 |
| United States | 1 |
| India | 1 |
Makers of External Urethral Occluder, Urinary Incontinence-Control, Female
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Guangdong Bingbing Health Care Products Ltd. | Jiangmen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products De Mexico S.A. De C.V. | La Mesa, Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products Inc. | Buena Park, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Universal Glove Company Limited | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sirona Hygiene Private Limited | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yearstar Healthcare Technology Co.,ltd | JIANGYIN Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 30, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.