Chemistry instrumentsLimited panel chemistry analysersUrine analysers
Automated urine analysers
EMDN code W020101020103
Manufacturers registered in Europe (EUDAMED) 15
- 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 |
|---|---|---|---|---|
| Zybio FDA EU representative : Lotus NL B.V. (Netherlands) | China | – 98/79 | PMS@zy-ivd.com EUDAMED record Report an error | |
| Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other | China |
4 others |
– 98/79 | EUDAMED record Report an error |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A, B IVDR | Website EUDAMED record Report an error | |
| Sysmex FDA EU representative : Sysmex Europe SE (Germany) | Japan | – 98/79 | ra_archive@sysmex.co.jp EUDAMED record Report an error | |
| Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland) | United States | A IVDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Arkray FDA EU representative : ARKRAY Europe, B.V. (Netherlands) | Japan |
|
– 98/79 | support_arkrayeurope@arkray.co.jp EUDAMED record Report an error |
| Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) | China | – 98/79 | Website export@keyubio.com EUDAMED record Report an error | |
| Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | – 98/79 | EUDAMED record Report an error | |
| Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | Website EUDAMED record Report an error | |
| Erba | Czechia | B IVDR | Website EUDAMED record Report an error | |
| Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) | China | A IVDR | info@infitek.com EUDAMED record Report an error | |
| Maccura EU representative : Humiss International B.V. (Netherlands) | China | B IVDR | Website EUDAMED record Report an error | |
| Shenzhen Landwind Biomedical Technology EU representative : Lotus NL B.V. (Netherlands) | China | A IVDR | sales@landwindmedical.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 |
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) 133
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 | K170587 (2017) |
| 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 |
| 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 |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | 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 URiSCAN 1 Ketones strip URiSCAN 2 ACR strip | registered |
| GERMAINE LABORATORIES, INC | United States | AIMSTRIP 10-SG AIMSTRIP US-9 AIMSTRIP US-11 AIMSTRIP US-5 AIMSTRIP US-4OB AIMSTRIP US-5B | K051727 (2005) |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| MOORE MEDICAL LLC | – | Moore Medical | registered |
| Immunostics Company, Inc | United States | Detector UA 2GP Detector UA 10SG Detector UA 10 Detector UA 5 Detector UA 2 | 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 |
| Nova Biomedical Corp. | United States | Nova Max NOVA STAT PROFILE | registered |
| STANBIO LABORATORY, L.P. | United States | Uri-Trak 120 M Urine Analyzer Uri-Chek 10SG Strips STAT-Site WB B-Ketone Test Strips STAT-Site B-HB Controls STAT-Site M B-HB Strips STAT-Site M B-HB Analyzer Pack | K902204 (1990) |
| ABBOTT DIABETES CARE INC Present in Europe in other categories | United States | FreeStyle Precision Pro Precision Xceed Pro Precision Xtra | K060768 (2006) |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | iChem® VELOCITY™ DxU | registered |
| LW SCIENTIFIC, INC. | United States | Urine Reagent Strips, 10-parameter Urine Reagent Strips, 5-parameter Urine Reagent Strips, 1-parameter, ketone Urine Reagent Strips, 2-parameter; glucose, protein | registered |
| 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 |
| 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 |
| Diagnostic Automation, Inc. | – | QMedix™ InstaTest | registered |
| FORA CARE INC. Present in Europe in other categories | Taiwan | FORA | 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) |
| 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 Tinaquant Albumin Tina-quant Albumin Gen.2 Tinaquant Albumin Gen2 | registered |
| i-SENS, Inc. Present in Europe in other categories | South Korea | KetoSens | K201551 (2020) |
| Contec Medical Systems Co., Ltd. Present in Europe in other categories | China | CONTEC | registered |
| MERCEDES MEDICAL, LLC | – | Tanner Scientific® | registered |
| AMVENTUREX, INC. | – | KETOCOACH BLOOD KETONE METER BIOCOACH Blood Glucose and Ketone Monitoring System BIOCOACH Blood Ketone Test Strips 50 Pack (Foil) KETOCOACH METER ONLY KETOCOACH CONTROL SOLUTION Level 2 KETOCOACH 50 BLOOD KETONE TEST STRIPS | registered |
| KETOBM USA LLC | – | KetoBM | registered |
| e-Linkcare Meditech Co., Ltd Present in Europe in other categories | China | Blood Ketone Control solution(level 1) Blood Ketone Control solution(level 2) Blood Ketone Monitoring System Blood Ketone Test Strips Blood Ketone Control solution(level 3) | registered |
| Ascensia Diabetes Care Holdings AG Present in Europe in other categories | United States | KETO-DIASTIX® KETOSTIX® | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | Pro Advantage | registered |
| REESE PHARMACEUTICAL COMPANY | – | TopCare DG Health | registered |
| Randox Laboratories, Ltd. Present in Europe in other categories | United Kingdom | D-3 Hydroxybutyrate (RANBUT) TOTAL PROTEIN (UP) | K951222 (1996) |
| 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 |
| FUTURE DIAGNOSTICS LLC | – | Care Touch | registered |
| Hearts Bio, Inc. | – | HeartsCare C1 Plus Multi-Functional Monitoring System heartscare B-Ketone Test Strips (10pcs/Box) | registered |
| Taidoc Technology Corporation Present in Europe in other categories | Taiwan | XPER Technology Procheck Witty Procheck Smart B-Ketone Test Strips XPER Technology Multi-Functional Monitoring System Procheck Smart XPER Technology Multi-Functional Monitoring System Procheck Witty | K173345 (2018) |
| 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 |
| Biorex Labs LLC | United States | K-CHECK DIAZO-CHEK | registered |
| Cardinal Health 110, Inc. | – | LEADER | registered |
| DiaSys Diagnostic Systems GmbH | Germany | β-Hydroxybutyrate 21 FS | registered |
| GEISS, DESTIN & DUNN, INC | – | GOODSENSE | registered |
| Genabio Diagnostics Inc. | – | GenaCheck Rapid Self-Test Kit For Urinary Tract Infections | registered |
| HORIBA INSTRUMENTS INCORPORATED | United States | Pointe Scientific, Inc. | 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 |
| Abbott Diagnostics Technologies AS Present in Europe in other categories | Norway | Alere Afinion™ ACR | registered |
| Adam Lawrence | – | bkt ß-Ketone Test Strips (50 pcs/box) | registered |
| Allied Medical, LLC Present in Europe in other categories | United States | PC | registered |
| BRUNO PHARMA INNOVATIONS, LLC | – | Bruno | registered |
| Changchun Lyz Technology Co., Ltd. | China | LYZ | registered |
| GOJJI, INC. | – | GOJJI BLOOD KETONE TEST STRIP | registered |
| Get Stix Inc. | – | Winx Health Inc | registered |
| HEALTHY.IO LTD Present in Europe in other categories | Israel | Minuteful - kidney test | K222921 (2023) |
| Jilin Test BIO-Electron Co.,Ltd | China | Metric | registered |
| Kunming Lianen Biotechnology Co., LTD | China | LOOKEE® AscleTrack™ Urine Microalbumin (MAU) Test Strip | registered |
| NOVODX Corporation | United States | GoldN Easy to Use Vaginal pH Test | registered |
| Rasimo Systems LLC | United States | SureMediks B-Ketone Test Strips (25pcs/box) | registered |
| SAVYON DIAGNOSTICS LTD | Israel | Feminine Screening Kit | registered |
| Serim Research Corp. | United States | Serim® PeriScreen™ Test Strips | K000578 (2000) |
| TRIVIDIA HEALTH, INC. | United States | TRUEplus | registered |
| VIDAN DIAGNOSTICS LLC | – | Lucidplus B-Ketone Test Strips 50 count | registered |
| WAL-MART STORES, INC. | – | RELI-ON® | registered |
| WALGREEN CO. | – | Walgreens | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| ATAGO CO., LTD. | Japan | – | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | K983774 (1999) |
| Accuster Technologies Pvt. Ltd. | India | – | registered |
| Apex BioTechnology Corp. Present in Europe in other categories | Taiwan | – | K182593 (2018) |
| Assure Tech. (Hangzhou) Co., Ltd. | China | – | registered |
| Atlas Medical Present in Europe in other categories | Jordan | – | registered |
| AusMed Global Limited | Hong Kong SAR China | – | registered |
| B&E BIO-TECHNOLOGY CO., LTD. Present in Europe in other categories | China | – | registered |
| BIOCHECK, INC. | United States | – | registered |
| BOEN HEALTHCARE CO., LTD. Present in Europe in other categories | 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 |
| Diagnostic Automation /Cortez Diagnostics Inc. | United States | – | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | – | registered |
| Diazyme Laboratories Present in Europe in other categories | United States | – | registered |
| Dongguan Honfield Precision Parts Co., Ltd | China | – | registered |
| Dylan Lucas International Inc | Canada | – | registered |
| E K INDUSTRIES, INC. | United States | – | registered |
| EAGLENOS SCIENCES, INC. Present in Europe in other categories | China | – | registered |
| ELHoda trade and supplies | Egypt | – | registered |
| FUBURG INDUSTRIAL CO., LTD. | Taiwan | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| GL DIABETES CORPORATION | United States | – | registered |
| General Life Biotechnology Co., Ltd. Present in Europe in other categories | Taiwan | – | registered |
| Global Instrumentation, LLC | United States | – | 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) |
The 100 most active manufacturers are shown, out of 133.
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