Stream Dx
The Stream Dx Uroflowmeter is intended to, under the direction of a medical professional, electronically record adult male patient voiding data to assist in the diagnosis of lower urinary…
The Stream Dx Uroflowmeter is intended to, under the direction of a medical professional, electronically record adult male patient voiding data to assist in the diagnosis of lower urinary tract disorders and is designed for home use. Stream Dx will calculate a patient’s flow rate and their maximum voided volume based on the collected data. This information will be provided to the caregiver by Stream Dx. The data obtained from the Stream Dx Uroflowmeter is meant to be used exclusively as a tool to aid in diagnosis of a condition. It is not intended to be used alone as the sole method of diagnosis.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
| Qingdao Unison Industries Co., Limited | Shandong | Shandong | Specification developer | 3 |
Record
| Listed by | Zien Medical Technologies LLC, United States |
|---|---|
| FDA product code | EXY |
| Device type | Uroflowmeter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-03-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SDX02 | In distribution | |
| SDX01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CarePath | Cleartrac Technologies, LLC | 5 |
| Fize kUO Console | Fize Research Ltd | 5 |
| Urocap IV Light | Laborie Medical Technologies, Canada ULC | 4 |
| proudP | Soundable Health, Inc. | 2 |
| Fize kUO Disposable Kit | Fize Research Ltd | 2 |
| Urocap III | Laborie Medical Technologies, Canada ULC | 2 |
| Rivus | Neurosoft, OOO | 2 |
| Fize kUO Disposable kit Pediatrics | Fize Research Ltd | 2 |
| EasyFlo Console | Srs Medical Systems, Inc. | 1 |
| EasyFlo Scale | Srs Medical Systems, Inc. | 1 |
| WiFLOW | Prometheus Group OF NEW Hampshire Limited, THE | 1 |
| Accuryn UO/T, Smart Cath Kit | Potrero Medical, Inc. | 1 |
Showing 12 of 30. All products under Uroflowmeter
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.