iUFlow
A uroflowmeter for measurement of urination (voiding) frequency, volume and flowrate of patients suffering from Lower Urinary Tract Symptoms (LUTS) when used in conjunction with the iUFlow…
A uroflowmeter for measurement of urination (voiding) frequency, volume and flowrate of patients suffering from Lower Urinary Tract Symptoms (LUTS) when used in conjunction with the iUFlow mobile application.
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 | Kesem Health PTY Ltd |
|---|---|
| FDA product code | EXY |
| Device type | Uroflowmeter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1800 |
| Premarket notification | Exempt |
| Record published | 2020-07-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 12 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IF2 | 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 |
| Stream Dx | Zien Medical Technologies LLC | 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 |
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.