Data / Medical devices / Bag, Urine Collection, Leg, For External Use, Non-Sterile
Bag, Urine Collection, Leg, For External Use, Non-Sterile (NNW): 73 FDA-registered makers in 10 countries
73 establishments in 10 countries are registered with the FDA to make Bag, Urine Collection, Leg, For External Use, Non-Sterile (product code NNW, Class 1, 21 CFR 876.5250). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NNW
- Device class
- 1
- Regulation
- 876.5250
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 37 |
| United States | 15 |
| India | 7 |
| Denmark | 3 |
| Mexico | 3 |
| Italy | 3 |
| Taiwan | 2 |
| Hungary | 1 |
| Latvia | 1 |
| Slovakia | 1 |
Makers of Bag, Urine Collection, Leg, For External Use, Non-Sterile
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 |
|---|---|---|---|---|---|---|---|---|
| Acosta Medical Group Inc. | Houston, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alimed, LLC | Dedham, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angiplast Pvt. Ltd. | Kheda Gujarat, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Ares Medical Technology Co.,ltd. | Tianchang Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Easyway Medical Supplies Co., Ltd | Tian Chang Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Medpurest Medical Technology Co.,ltd | Anqing Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Kangmingna Packaging Co.,ltd | Anqing Anhui, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell Healthcare Products LLC | Reno, NV, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alltrista Plastics LLC | Reedsville, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansell Sandel Medical Solutions LLC | Chatsworth, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beauxregard Industries | Sarasota, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Winsunny Harmony Science&technology Co., Ltd. | Bei jing Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinisupplies (nanjing) Co., Ltd | Nanjing Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast (china) Ltd. | ZHUHAI Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast A/S | HUMLEBAEK Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast Hungary KFT | TATABANYA Komarom-Esztergom, Hungary | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Shuyang Co., Ltd. | Shuyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Create Biotech Co., Ltd. | Taoyuan City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Co.,Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diatrust Medical Co., Ltd. | Nanjing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| David Scott Company. | Franklin, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evereast Medical Products Group Co., Ltd | Changyuan City Henan, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Hongfeng Co.,ltd | Foshan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greystone Medical, LLC | Waterford, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Mlush Sanitary Products Co.,ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Aile Industrial Co., Ltd. | zhengzhou Henan, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henrotek A/S | Roedding Syddanmark, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hill-Rom De Mexico S De RL De CV | APODACA Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hill-Rom, Inc. | Batesville, IN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Hendry Medical Appliance Co., Ltd | Xiaogan City Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Medical India Private Limited | Bawal, Rewari Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jcmed Tianjin Import And Export Co., Ltd | Tianjin, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Hongxin Medical Technology Co, Ltd. | Shuyang City Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangjin Medical Instrument Co.,ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Ostup Medical Products Co. Ltd. | Nanjing Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Rongye Technology Co.,ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K-Med Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kova International Inc | Garden Grove, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Aoke Medical Equipment Co.,ltd. | Lianyungang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meus SRL | Piove di Sacco Padova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mozarc Medical Italy | Mirandola Modena, Italy | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Risenmed Technology Co.,ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Yingmed Medical Instruments Co.,ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Para El Cuidado De La Salud | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Posey, S. de R.L. de C.V. | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ribbel International Ltd. | SONEPAT Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ROLL Srl | Piove di Sacco Padova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Romsons International | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Giftshine Technology Co Ltd | SHENZHEN Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Hengdasheng Technology Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SIA Elas Baltic | Jelgava, Latvia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skil-Care Corp. | New Rochelle, NY, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suru International Pvt Ltd | DAHANU Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Meccan Import and Export Corp. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TF New Material Sci And Tec Co.,ltd | Huainan Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tytex Denmark A/S | IKAST Midtjylland, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tytex Slovakia S.R.O. | HUMENNE Presovsky, Slovakia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Urocare Products, Inc. | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valentine Intl. Ltd. | Hsichih City, Taipei Hsien, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velcro (china) Fastening Systems Company Limited | ZHANGJIAGANG Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhangjiagang Shengang Medical Products Co.,ltd | Zhangjiagang Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Lidesen Medical Instrument Co., Ltd | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.