Chemistry instrumentsLimited panel chemistry analysersUrine analysers
Automated urine analysers - consumables
EMDN code W020101020185
Manufacturers registered in Europe (EUDAMED) 4
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) | United States | A, B IVDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Urit FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR | Website service@uritest.com EUDAMED record Report an error | |
| Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands) | Japan | A IVDR, 98/79 | support_arkrayeurope@arkray.co.jp EUDAMED record Report an error | |
| Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany) | China |
|
– 98/79 | Website EUDAMED record Report an error |
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) 92
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 |
|---|---|---|---|
| ACON Laboratories, Inc. | United States | Mission Urinalysis Reagent Strips Mission U120 Smart Urine Analyzer Mission U120 Touch Urine Analyzer HealthyMe UTI Urinary Tract Infection Test Strips Mission Urinary Tract Infection (UTI) Test strips | K063295 (2007) |
| TECO DIAGNOSTICS | United States | TECO DIAGNOSTICS Teco Diagnostics Uritek TC-201 Urine Chemistry Test System Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer System Teco Diagnostics Uritek TC-720+ Urine Chemistry Test System | K170118 (2017) |
| Hangzhou AllTest Biotech Co., Ltd. Present in Europe in other categories | China | Alltest Urinary Tract Infection Test Discover Multi-Drug Test Cup Alltest Multi-Drug 14 Drugs Test Cup Multi-Drug Test Cup (Urine) Discover Multi-Drug 12 Drugs Rapid Test Cup Alltest Multi-Drug 14 Drugs Urine Test Panel | K252607 (2025) |
| BTNX Inc | – | Rapid Response | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| DFI CO.,LTD Present in Europe in other categories | South Korea | One+Step 10A CYBOW 10 Yodoc 10 QTEST™ 11 CYBOW 11 One+Step UTI | registered |
| YD Diagnostics CORP. Present in Europe in other categories | South Korea | UCARE 11 Stick URiSCAN 10 SGL strip URiSCAN 10 ACR strip URiSCAN 6 L strip | registered |
| GERMAINE LABORATORIES, INC | United States | AIMSTRIP 10-SG AIMSTRIP US-11 AIMSTRIP US-9 AIMSTRIP US-4OB AIMSTRIP US-5B AIMSTRIP US-5 | K051727 (2005) |
| Nova Biomedical Corp. | United States | STAT PROFILE | registered |
| MOORE MEDICAL LLC | – | Moore Medical | registered |
| Immunostics Company, Inc | United States | Detector UA 2GP Detector UA 10SG Detector UA 10 Detector UA 5 | registered |
| JANT PHARMACAL CORPORATION | – | Accustrip 10-Parameter Urine Reagent Strip Accutest Accustrip URS Strips + Reader | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | iChem® VELOCITY™ DxU | registered |
| PEPTONIC MEDICAL ISRAEL LTD Present in Europe in other categories | – | Equate VS-SENSE OTC Nuvetest VagiVital VS Screening Kit for Vaginal Health Florisense Preconception Vaginal Health Test | registered |
| Safecare Biotech (Hangzhou) Co., Ltd. Present in Europe in other categories | China | Exploro Urinary Tract Infection (UTI) Test T Testahead URINARY TRACT INFECTION TEST Welcheck URINARY TRACT INFECTION TEST URINARY TRACT INFECTION TEST | K242767 (2025) |
| EASY HEALTHCARE CORPORATION | – | Easy@Home Urinary Tract Infection Test Strips (10 Pack) Easy@Home Urinary Tract Infection Test Strips (20 Pack) Areta Ketone Urinalysis Reagent Strips (100 tests kit） Areta 10 Parameters Urinalysis Reagent Strips (100 tests kit） Areta 10 Parameters Urinalysis Reagent Strips （50 tests kit） Areta pH Urinalysis Reagent Strips (100 tests kit） | registered |
| LW SCIENTIFIC, INC. | United States | Urine Reagent Strips, 10-parameter Urine Reagent Strips, 5-parameter | registered |
| STANBIO LABORATORY, L.P. | United States | Uri-Trak 120 M Urine Analyzer Uri-Chek 10SG Strips | registered |
| Diagnostic Automation, Inc. | – | QMedix™ | registered |
| Contec Medical Systems Co., Ltd. Present in Europe in other categories | China | CONTEC | registered |
| MERCEDES MEDICAL, LLC | – | Tanner Scientific® | registered |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | Pro Advantage | registered |
| REESE PHARMACEUTICAL COMPANY | – | TopCare DG Health | registered |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | CHEMSTRIP 10 UA TEST STRIPS Chemstrip 7 Test Strips Chemstrip 5 OB Test Strips Chemstrip 2 LN Test Strips | registered |
| VIVOSENS INC. | United States | Vivoo At-Home Urinary Tract Infection Test Vivoo At-Home UTI Test Strips | registered |
| APOTHECARY PRODUCTS, LLC | United States | Ezy Dose Diabetic Specialty Solutions | registered |
| Weihai Kangzheng Medical Equipment Technology Co., Ltd | – | urinalysis strips | registered |
| ACESO LABORATORIES INC. Present in Europe in other categories | United States | Atida Urinary Tract Infection Test | registered |
| Cardinal Health 110, Inc. | – | LEADER | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| GEISS, DESTIN & DUNN, INC | – | GOODSENSE | registered |
| Genabio Diagnostics Inc. | – | GenaCheck Rapid Self-Test Kit For Urinary Tract Infections | registered |
| REICHERT, INC. Present in Europe in other categories | United States | Clinical Refractometers Reichert® Digital Clinic-Chek Reichert® Digital USG-Chek | registered |
| RICCA CHEMICAL COMPANY LLC | United States | Ricca Chemical Company® | registered |
| SCI Medic, Inc. | – | NEW CHOICE | registered |
| Allied Medical, LLC Present in Europe in other categories | United States | PC | registered |
| Biorex Labs LLC | United States | DIAZO-CHEK | registered |
| Get Stix Inc. | – | Winx Health Inc | registered |
| Jilin Test BIO-Electron Co.,Ltd | China | Metric | registered |
| NOVODX Corporation | United States | GoldN Easy to Use Vaginal pH Test | registered |
| SAVYON DIAGNOSTICS LTD | Israel | Feminine Screening Kit | registered |
| Serim Research Corp. | United States | Serim® PeriScreen™ Test Strips | K000578 (2000) |
| WALGREEN CO. | – | Walgreens | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| ATAGO CO., LTD. | Japan | – | registered |
| AVE Science & Technology Co., Ltd Present in Europe in other categories | China | – | registered |
| Accuster Technologies Pvt. Ltd. | India | – | registered |
| Atlas Medical Present in Europe in other categories | Jordan | – | registered |
| BOEN HEALTHCARE CO., LTD. Present in Europe in other categories | China | – | registered |
| Changchun Lyz Technology Co., Ltd. | China | – | registered |
| Changchun Merydi Bio-Tech Co., Ltd. | China | – | registered |
| Changchun Wancheng Bio-Electron Co., Ltd. | China | – | registered |
| Chungdo Pharm. Co., Ltd. | South Korea | – | 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 |
| Dylan Lucas International Inc | Canada | – | registered |
| ELHoda trade and supplies | Egypt | – | registered |
| FUBURG INDUSTRIAL CO., LTD. | Taiwan | – | registered |
| HONG KONG MEDSOURCING LIMITED | Hong Kong SAR China | – | registered |
| HUZHOU JUNDA INDUSTRY CO., LTD. | China | – | registered |
| Healgen Scientific,, LLC Present in Europe in other categories | United States | – | K251800 (2025) |
| Henso Medical (Hangzhou) Co., Ltd. | China | – | registered |
| Human Metabolomics Institute, Inc. | China | – | registered |
| Human Power of N | United States | – | registered |
| Jiangsu Medomics Medical Technology 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 |
| LABOTECH MICROSCOPES INDIA PRIVATE LIMITED | India | – | registered |
| Lords Mark Global LLC | United States | – | registered |
| MACHEREY-NAGEL GMBH & CO. KG. Present in Europe in other categories | Germany | – | registered |
| Mainline Medical Dental Supply | Canada | – | registered |
| Nihon Seimitsu Sokki Co., Ltd. Present in Europe in other categories | Japan | – | registered |
| PRESTIGE BRANDS HOLDINGS, INC. | United States | – | registered |
| Platinum Focus Group Ltd. | United Kingdom | – | registered |
| RHA Investment limited | Ireland | – | registered |
| Randox Laboratories, Ltd. Present in Europe in other categories | United Kingdom | – | registered |
| Roche Diagnostics Operations Inc. | United States | – | registered |
| SENSOR HEALTH PRODUCTS, INC. | Canada | – | registered |
| SHANGHAI YOUDING INTERNATIONAL TRADE CO., LTD. | China | – | registered |
| SST International Inc. | United States | – | registered |
| Sanicure BV | Netherlands | – | 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 |
| Tyros Biopharma Inc. | Canada | – | registered |
| VWR INTERNATIONAL, LLC Present in Europe in other categories | United States | – | registered |
| WIENER LABORATORIOS S.A.I.C. Present in Europe in other categories | Argentina | – | registered |
| Weihai Kangzheng Medical Equipments Technology Co.,Ltd | China | – | registered |
| Zhejiang Orient Gene Biotech Co., Ltd Present in Europe in other categories | China | – | registered |
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.
Related categories
- Urine strip readers19 manufacturers
- Semi-automated urine analysers17 manufacturers
- Automated urine analysers15 manufacturers
- Automated urine analysers - IVD medical device software2 manufacturers
- Automated urine analysers - software accessories1 manufacturer
- Automated urine analysers - hardware accessories1 manufacturer
- Parent category : Urine analysers40 manufacturers