Data / Medical devices / Device, Paste-On For Incontinence, Sterile
Device, Paste-On For Incontinence, Sterile (EXI): 8 FDA-registered makers in 2 countries
8 establishments in 2 countries are registered with the FDA to make Device, Paste-On For Incontinence, Sterile (product code EXI, 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 7 510(k) clearances under this code, the latest on August 28, 1997, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EXI
- Device class
- 1
- Regulation
- 876.5250
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 6 |
| United States | 2 |
Makers of Device, Paste-On For Incontinence, 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 |
|---|---|---|---|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Shuyang Co., Ltd. | Shuyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Co.,Limited | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Primecare Medical Co.,Ltd. | hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omni Measurement Systems, Inc. | Colchester, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primecare Medical (Suzhou) Co.,Ltd. | Changshu Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Jinlai Huanhai Medical Technology Co.,ltd | Yantai Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 28, 1997. 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.