Data / Medical devices / Urinometer, Mechanical
Urinometer, Mechanical (EXR): 10 FDA-registered makers in 6 countries
10 establishments in 6 countries are registered with the FDA to make Urinometer, Mechanical (product code EXR, Class 2, 21 CFR 876.1800). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on May 17, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EXR
- Device class
- 2
- Regulation
- 876.1800
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Mexico | 2 |
| United Kingdom | 2 |
| Taiwan | 1 |
| China | 1 |
| Japan | 1 |
Makers of Urinometer, Mechanical
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 |
|---|---|---|---|---|---|---|---|---|
| Achb Enterprise Co., Ltd. | Tainan, Taiwan | Contract manufacturer | 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 | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health (Kenmex Medical Specialties) | TIJUANA Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical (dongguan) Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nihon Seimitsu Sokki Co., Ltd. | SHIBUKAWA Gunma, Japan | Manufacturer, Specification developer | 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 | |
| Professional Specialties Co., Inc. | Memphis, TN, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 17, 1994. 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.