IVD instrumentsChemistry / immunochemistry instruments
Urinalysis (ur) - laboratory analysers
EMDN code W020107
Manufacturers registered in Europe (EUDAMED) 17
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 53
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Siemens Healthcare Diagnostics, Inc. Present in Europe in other categories | United States | CLINITEK Status®+ Analyzer CLINITEK Novus® Automated Urine Chemistry Analyzer CLINITEK Status® Connector Clinitek Atlas® Calibration Kit Clinitek Atlas® 10 Reagent PAK for Urine Chemistry Clinitek Atlas® Calibrator #4 | K140717 (2014) |
| ARKRAY USA, INC. Present in Europe in other categories | United States | Concentrated Washing Solution 3 AUTION™ Uriflet 9HA Test Strips AUTION EYE™ Control Solution H/L AUTION™ Sticks 10EA Test Strips AUTION™ MAX AX-4030 Analyzer AUTION EYE™ Calibrator Focus/Calibrator | K121456 (2013) |
| Urit Medical Electronic Co., Ltd. Present in Europe in other categories | United States | URINE REAGENT STRIPS Urine Strips URINE ANALYZER Automatic Urine Analyzer | registered |
| GERMAINE LABORATORIES, INC | United States | AIMSTRIP US-3 AIMSTRIP US-K AIMSTRIP US-4OB AIMSTRIP US-9 AIMSTRIP URINE ANALYZER AIMSTRIP US-2 | registered |
| ACON Laboratories, Inc. | United States | Mission U120 Smart Urine Analyzer Mission U120 Touch Urine Analyzer Mission U120 Urine Analyzer MISSION U500 URINE ANALYZER | K142543 (2015) |
| BTNX Inc | – | Rapid Response | registered |
| TECO DIAGNOSTICS | United States | Teco Diagnostics Uritek TC-201 Urine Chemistry Test System TECO DIAGNOSTICS Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System | K051526 (2005) |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| MOORE MEDICAL LLC | – | Moore Medical | registered |
| STANBIO LABORATORY, L.P. | United States | Uri-Trak 120 M Urine Analyzer Uri-Trak 120 Analyzer Uri-Trak 120 Analyzer Refurbished | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| Hemocue AB Present in Europe in other categories | United States | HemoCue® Urine Albumin Microcuvettes HemoCue® Albumin 201 Analyzer | K053253 (2006) |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| S-CONNECT CO.,LTD | – | My Yodoc | registered |
| Contec Medical Systems Co., Ltd. Present in Europe in other categories | China | CONTEC | registered |
| HEALTHY.IO LTD Present in Europe in other categories | Israel | Minuteful - kidney test | registered |
| Kunming Lianen Biotechnology Co., LTD | China | LOOKEE® AscleTrack™ Urine Test Analyzer | registered |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | Pro Advantage | registered |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | cobas u 601 urine analyzer | K093555 (2010) |
| Sciteck Diagnostics, Inc. | United States | Sciteck | K954514 (1996) |
| 77 Elektronika Kft. | Hungary | – | registered |
| ARI Medical Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| AVE Science & Technology Co., Ltd Present in Europe in other categories | China | – | registered |
| Accuster Technologies Pvt. Ltd. | India | – | registered |
| Arkray Factory USA, Inc. Present in Europe in other categories | United States | – | registered |
| Changchun Merydi Bio-Tech Co., Ltd. | China | – | registered |
| Changchun Wancheng Bio-Electron Co., Ltd. | China | – | registered |
| DIRUI INDUSTRIAL CO., LTD. Present in Europe in other categories | China | – | registered |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Dongguan Honfield Precision Parts Co., Ltd | China | – | registered |
| Healgen Scientific,, LLC Present in Europe in other categories | United States | – | registered |
| High Technology, Inc. Present in Europe in other categories | United States | – | registered |
| Infitek Co., Ltd. Present in Europe in other categories | China | – | registered |
| Jilin Hongyi Bio-Tech Co., Ltd. | China | – | registered |
| KIMBALL SOLUTIONS GROUP, LLC | United States | – | registered |
| Labpeak Co.,Ltd | China | – | registered |
| Lords Mark Global LLC | United States | – | registered |
| MACHEREY-NAGEL GMBH & CO. KG. Present in Europe in other categories | Germany | – | registered |
| ORTA MEDICAL LTD | Israel | – | registered |
| Q-Line Biotech Limited | India | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SST International Inc. | United States | – | registered |
| STS Corporation | United States | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Sciteck | United States | – | registered |
| Scitek Global Co.,Ltd | China | – | registered |
| Seacomp Displays | Mexico | – | registered |
| Starling Medical | United States | – | registered |
| Sysmex America, Inc. Present in Europe in other categories | United States | – | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
| UAB KITRON | Lithuania | – | registered |
| Weihai Kangzheng Medical Equipments Technology Co.,Ltd | China | – | registered |
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