Fize kUO Console
FIZE kUO Console 2.4G catalog number: FI-FG00-KU00-0005 FIZE kUO Console 2.4G with power box US catalog number: FKUO2.4G_PB_US FIZE kUO Console 2.4G with power supply US catalog number:…
FIZE kUO Console 2.4G catalog number: FI-FG00-KU00-0005 FIZE kUO Console 2.4G with power box US catalog number: FKUO2.4G_PB_US FIZE kUO Console 2.4G with power supply US catalog number: FKUO2.4G_PS_US
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 | Fize Research Ltd |
|---|---|
| FDA product code | EXY |
| Device type | Uroflowmeter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1800 |
| Premarket notification | Exempt |
| Record published | 2024-02-28 |
| Record revised | 2025-04-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | With power box, with power supply, box |
| Distribution end date | 2025-04-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.4G2 | In distribution | |
| 5G1 | In distribution | |
| 2.4G1 | In distribution | |
| 5G2 | In distribution | |
| FI-FGUS-KU00-0001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CarePath | Cleartrac Technologies, LLC | 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 |
| 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.