Data / Medical devices / Drape, Urological, Disposable
Drape, Urological, Disposable (EYY): 25 FDA-registered makers in 6 countries
25 establishments in 6 countries are registered with the FDA to make Drape, Urological, Disposable (product code EYY, Class 2, 21 CFR 878.4370). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on May 14, 1985, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EYY
- Device class
- 2
- Regulation
- 878.4370
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| Vietnam | 7 |
| United States | 7 |
| Mexico | 4 |
| Dominican Republic | 3 |
| China | 3 |
| India | 1 |
Makers of Drape, Urological, Disposable
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 |
|---|---|---|---|---|---|---|---|---|
| 3M Edumex, S.A De C.V | CD. JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bong Bach Tuyet Joint Stock Company | Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health D.R. 203 Ii Ltd | Santo Domingo, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Daemyung Chemical Co., Ltd (vietnam) | An Phuoc Commune Dong Nai, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Das Medical International, SRL | La Romana, Dominican Republic | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endonest Medical Systems LLP | PALGHAR Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hanh Minh Manufacturing Trading Company Limited | Bien Hoa Dong Nai, Vietnam | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Medplus Non-Woven Manufacturer Co.,ltd. | Siyang 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 | |
| Microtek Dominicana, S.A.S. | La Romana, Dominican Republic | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Medical LLC | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PROCEPT BioRobotics Corporation | San Jose, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation | Dien Ban Bac Ward Da Nang, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| QUIROPRODUCTOS DE CUAUHTEMOC S. de R.L. de C.V. | CUAUHTEMOC, CHIHUAHUA Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quiroproductos de Cuauhtemoc S. De R.L. de C.V. | Cuauhtemoc Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SOLVENTUM US LLC (Apodaca) | Apodaca Nuevo Leon, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stevimed Medical Joint Stock Company | Can Giuoc Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Joy Crown Industry Co., Ltd | Pu Dong New Area Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | Brookings, SD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vien Phat Import Export Service Trading Joint Stock Company | Ben Thanh Ward Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VT Production Medical Materials Production Corporation | Can Giuoc Commune Tay Ninh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 14, 1985. 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.