Data / Medical devices / Catheter, Upper Urinary Tract
Catheter, Upper Urinary Tract (EYC): 7 FDA-registered makers in 5 countries
7 establishments in 5 countries are registered with the FDA to make Catheter, Upper Urinary Tract (product code EYC, Class 2, 21 CFR 876.5130). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on October 15, 2020, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EYC
- Device class
- 2
- Regulation
- 876.5130
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Finland | 1 |
| India | 1 |
| Israel | 1 |
| Costa Rica | 1 |
Makers of Catheter, Upper Urinary Tract
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 |
|---|---|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 2 | October 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| AirLife Finland Oy | Helsinki Uusimaa, Finland | Specification developer | 1 | August 18, 2006 | 0 | 0 | 0 | api.fda.gov |
| Degania Medical Devices Pvt. Ltd. | GURGAON Haryana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Degania Silicone, Ltd. | DEGANIA BET Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Cientifica De Latinoamerica S.R.L. | La Aurora, Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xeridiem Medical Devices | Tucson, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 15, 2020. 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.