Fize kUO Disposable Pediatrics Kit, Urinometer
FIZE kUO Disposable Pediatrics kit, Urinometer catalog number for 1 pc: FI-KTUS-KU01-0155 FIZE kUO Disposable Pediatrics kit, Urinometer catalog number for 20 pcs: FI-FGUS-KU03-0028
7manufacturers in China registered for this device type
1catalogue number
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 | 2025-04-28 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G1 | 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.