Chemistry / immunochemistry instrumentsChemistry instrumentsLimited panel chemistry analysers
Urine analysers
EMDN code W0201010201
Manufacturers registered in Europe (EUDAMED) 40
- 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 | A IVDR, 98/79 | PMS@zy-ivd.com EUDAMED record Report an error | |
| Dirui FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other | China |
5 others |
A IVDR, 98/79 | EUDAMED record Report an error |
| Sysmex FDA EU representative : Sysmex Europe SE (Germany) | Japan |
1 other |
A IVDR, 98/79 | ra_archive@sysmex.co.jp 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 |
| Mindray FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A, B IVDR | Website EUDAMED record Report an error | |
| Aconbio EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | Website 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 |
| Erba | Czechia | A, B IVDR | Website EUDAMED record Report an error | |
| Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other | China | A IVDR, 98/79 | Website export@keyubio.com EUDAMED record Report an error | |
| Macherey-Nagel FDA | Germany | A IVDR | Website sales@mn-net.com EUDAMED record Report an error | |
| Beijing Lepu Medical Technology EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Contecmed FDA EU representative : Prolinx GmbH (Germany) | China | A IVDR | Website pms.qms@contecmed.com EUDAMED record Report an error | |
| High Technology FDA EU representative : MedEnvoy Global BV (Netherlands) | United States | A IVDR | Website EUDAMED record Report an error | |
| Infitek FDA EU representative : Kingsmead Service B.V. (Netherlands) and 1 other | China | A IVDR | info@infitek.com EUDAMED record Report an error | |
| Maccura EU representative : Humiss International B.V. (Netherlands) | China | A, B IVDR | Website EUDAMED record Report an error | |
| Shandong Bohong Gene Technology EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| TestCard EU representative : CS Life Sciences Europe Ltd (Ireland) | United Kingdom (ex Northern Ireland) | A IVDR | Website info@testcard.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 | |
| AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | – 98/79 | EUDAMED record Report an error | |
| Bioantibody Biotechnology EU representative : Medunion S.L. (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| BioFynder EU representative : SUNGO Europe B.V. (Netherlands) | United Kingdom (ex Northern Ireland) | A IVDR | EUDAMED record Report an error | |
| Boditech FDA EU representative : Obelis s.a. (Belgium) | South Korea | A IVDR | Website marketing@boditech.co.kr EUDAMED record Report an error | |
| Diagnostics | Belgium | A IVDR | Website EUDAMED record Report an error | |
| Diasia FDA EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | Website EUDAMED record Report an error | |
| Doasense | Germany | A IVDR | Website info@doasense.de EUDAMED record Report an error | |
| Healthy FDA EU representative : AR Experts B.V. (Netherlands) | Israel |
|
– 98/79 | Website EUDAMED record Report an error |
| Hivis Medical Technology EU representative : Sungo Cert GmbH (Germany) | China |
|
– 98/79 | EUDAMED record Report an error |
| Humadx EU representative : Human Gesellschaft für Biochemica und Diagnostica mbH (Germany) | China | A IVDR | service@humadx.com.cn EUDAMED record Report an error | |
| Iki | France | A IVDR | contact@iki-diag.com EUDAMED record Report an error | |
| Jiangsu Jinzhun Biotech EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Konsung FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
A IVDR | EUDAMED record Report an error |
| Lordsmark EU representative : Obelis s.a. (Belgium) | India | A IVDR | Website EUDAMED record Report an error | |
| Mr International Healthcare Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) | China |
|
A IVDR | EUDAMED record Report an error |
| Poweam EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Sanymed | Italy | A IVDR | Website info@sanymed.it 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 | |
| Sugentech FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | B IVDR | ra@sugentech.com EUDAMED record Report an error | |
| Yercon Diagnostic EU representative : CMC Medical Devices & Drugs SL (Spain) | China | A IVDR | Website EUDAMED record Report an error | |
| Chongqing Aolun Technology EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market | China |
|
A IVDR | 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) 197
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 Mission U120 Urine Analyzer | 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 Teco Diagnostics TC Matrix Clinical Chemistry Analyzer Teco Diagnostics Chemistry Calibrator | K170118 (2017) |
| Nova Biomedical Corp. | United States | Nova Max NOVA STAT PROFILE NOVA/STAT PROFILE | K897177 (1990) |
| 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 |
| 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) |
| 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 URiSCAN 1 Ketones strip URiSCAN 2 ACR strip | K141874 (2015) |
| Chromsystems Instruments + Chemicals GmbH | Germany | Plasma Calibrator Set Plasma Calibration Standard Serum Calibrator Set Serum Calibration Standard Urine Calibration Standard Whole Blood Calibration Standard | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | iChem® VELOCITY™ DxU AU Synchron IMMAGE Access Total BhCG (5th IS) Calibrators | K141388 (2014) |
| MOORE MEDICAL LLC | – | Moore Medical | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | 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 |
| 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 | K133330 (2013) |
| Abbott Laboratories Present in Europe in other categories | United States | Alinity ARCHITECT | K123372 (2013) |
| Bio-Rad Present in Europe in other categories | United States | BioPlex 2200 | K832695 (1983) |
| Phoenix Diagnostics, Inc. | United States | Phoenix Diagnostics PHOENIX DIAGNOSTICS, INC. | K023268 (2002) |
| 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 | K032936 (2004) |
| Radiometer Medical ApS Present in Europe in other categories | Denmark | ABL80 SC80 ABL90 Sensor Cassette pack ABL90 FLEX PLUS Analyzer SC90 50 BG, LYT, MET, OXI + QC ABL90 FLEX Analyzer 925-047 ABL90 FLEX inlet clip | 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 Urine Reagent Strips, 1-parameter, ketone Urine Reagent Strips, 2-parameter; glucose, protein | registered |
| Verichem Laboratories, Inc. | United States | Total Protein / Albumin Standard Kit Serum ISE Standard Kit Carbon Dioxide Standard Kit Iron Standard Kit Urine Chemistry Standard Kit Carbon Dioxide Standard | K112834 (2012) |
| Diagnostic Automation, Inc. | – | QMedix™ InstaTest | registered |
| ABBOTT DIABETES CARE INC Present in Europe in other categories | United States | FreeStyle Precision Pro Precision Xceed Pro Precision Xtra | K060768 (2006) |
| Inova Diagnostics, Inc. Present in Europe in other categories | United States | Aptiva® APS IgA Calibrators QUANTA Flash® h-tTG IgG Calibrators QUANTA Flash® Centromere Calibrators QUANTA Flash® GBM Calibrators QUANTA Flash® DGP IgG Calibrators QUANTA Flash® DGP Screen Calibrators | registered |
| CAROLINA LIQUID CHEMISTRIES CORPORATION | United States | CAROLINA LIQUID CHEMISTRIES CORP.® SERUM CAL KIT Product No. 28200 CAROLINA LIQUID CHEMISTRIES CORP.™ SYNCHRON CX® CAL 2 CC909 CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 CO2 RGT KIT Product No. ST313 CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT BL-313 CAROLINA LIQUID CHEMISTRIES CORP.® CO2 RGT. KIT AU-313 CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910 | registered |
| MERCEDES MEDICAL, LLC | – | Tanner Scientific® | registered |
| FORA CARE INC. Present in Europe in other categories | Taiwan | FORA | registered |
| Randox Laboratories, Ltd. Present in Europe in other categories | United Kingdom | D-3 Hydroxybutyrate (RANBUT) TOTAL PROTEIN (UP) SP CAL (LIQ) CAL 3 CAL 2 CAL B | K061056 (2006) |
| Siemens Healthcare Diagnostics Products GmbH Present in Europe in other categories | Germany | N Protein Standard SL N Rheumatology Standard SL Dimension Vista® PROT1 CAL N Protein Standard UY DImension Vista® Protein 3 Calibrator N Apolipoprotein Standard Serum | registered |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | Pro Advantage | registered |
| i-SENS, Inc. Present in Europe in other categories | South Korea | KetoSens | K201551 (2020) |
| REESE PHARMACEUTICAL COMPANY | – | TopCare DG Health | registered |
| VIVOSENS INC. | United States | Vivoo At-Home Urinary Tract Infection Test Vivoo At-Home UTI Test Strips | registered |
| WATERS TECHNOLOGIES CORPORATION Present in Europe in other categories | – | MassTrak | registered |
| HORIBA ABX SAS Present in Europe in other categories | France | ABX PENTRA REFERENCE 280ML ABX PENTRA STANDARD 2 ABX PENTRA MULTICAL Yumizen C1200 Protein Cal ABX PENTRA STANDARD 1 Yumizen C1200 Multi Cal | K071779 (2008) |
| HORIBA INSTRUMENTS INCORPORATED | United States | Pointe Scientific, Inc. Pointe Scientific, Inc. Microprotein POINTE Chemistry Calibrator Set POINTE SCIENTIFIC Chemistry Calibrator | registered |
| INFRARED LABORATORY SYSTEMS LLC | United States | Synermed® | 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 |
| APOTHECARY PRODUCTS, LLC | United States | Ezy Dose Diabetic Specialty Solutions | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| Lacar MDX Technologies Present in Europe in other categories | Belgium | SEEKER® | registered |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | K161140 (2016) |
| TOKYO BOEKI MEDISYS INC. | United States | Calibrator 2 Urine Calibrator Set Calibrator 1 Calibrator SET A, B Dialysis Calibrator | registered |
| Weihai Kangzheng Medical Equipment Technology Co., Ltd | – | urinalysis strips | registered |
| DREW SCIENTIFIC, INC. | United Kingdom | JAS Diagnostics | 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 |
| ACESO LABORATORIES INC. Present in Europe in other categories | United States | Atida Urinary Tract Infection Test | registered |
| Ascensia Diabetes Care Holdings AG Present in Europe in other categories | United States | KETO-DIASTIX® KETOSTIX® | registered |
| Cardinal Health 110, Inc. | – | LEADER | 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 |
| SENTINEL CH. SPA Present in Europe in other categories | Italy | Plasmaproteins Cal 3x Lipase NG Cal Clin Chem Cal | K081533 (2008) |
| Solomon Park Research Laboratories, Inc. | United States | Solomon Commutable Quality Materials | registered |
| ALFA WASSERMANN, INC. | United States | Alfa Wassermann | registered |
| Biorex Labs LLC | United States | K-CHECK DIAZO-CHEK | registered |
| DiaSys Diagnostic Systems GmbH | Germany | β-Hydroxybutyrate 21 FS β-Hydroxybutyrate 21 Linearity Standards | registered |
| Edan Instruments, Inc. Present in Europe in other categories | China | Calibrant Fluid Pack Blood Gas and Chemistry Analyzer | 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 |
| JEOL LTD. | Japan | ISE Serum Standard Set NA Internal Standard ISE Urine Standard Set | 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) |
| Allied Medical, LLC Present in Europe in other categories | United States | PC | registered |
| DENKA COMPANY LIMITED | Japan | Lipid Calibrator S small dense LDL Calibrator | registered |
| Get Stix Inc. | – | Winx Health Inc | registered |
| Hemocue AB Present in Europe in other categories | United States | HemoCue® Urine Albumin Microcuvettes HemoCue® Albumin 201 Analyzer | K053253 (2006) |
| Jilin Test BIO-Electron Co.,Ltd | China | Metric | registered |
| Kamiya Biomedical Co. Present in Europe in other categories | United States | K-ASSAY® Multi-Analyte Calibrator K-ASSAY® Apo AI/B Calibrator | K993853 (1999) |
| Kunming Lianen Biotechnology Co., LTD | China | LOOKEE® AscleTrack™ Urine Microalbumin (MAU) Test Strip LOOKEE® AscleTrack™ Urine Test Analyzer | registered |
| Microgenics Corporation Present in Europe in other categories | United States | CEDIA Core TDM Multi-Calibrators CEDIA Cardiac TDM Multi-Calibrators | registered |
| NOVODX Corporation | United States | GoldN Easy to Use Vaginal pH Test | registered |
| S-CONNECT CO.,LTD | – | My Yodoc | registered |
| SAVYON DIAGNOSTICS LTD | Israel | Feminine Screening Kit | registered |
| Sekisui Diagnostics, LLC Present in Europe in other categories | United States | MICROALBUMIN Calibrators DC-CAL Calibrator | registered |
| Serim Research Corp. | United States | Serim® PeriScreen™ Test Strips | K000578 (2000) |
| WALGREEN CO. | – | Walgreens | registered |
| 5-Diagnostics Ltd | Switzerland | 5-PLASMA Bivalirudin Calibrator | 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 |
| BRUNO PHARMA INNOVATIONS, LLC | – | Bruno | registered |
| CLEARCHEM DIAGNOSTICS INC. | – | ClearChem Diagnostics Inc. MicroProtein, Total | registered |
| CLINICAL DIAGNOSTIC SOLUTIONS, INC. Present in Europe in other categories | United States | Chemistry Calibrator Set | registered |
| Changchun Lyz Technology Co., Ltd. | China | LYZ | registered |
| Diamond Diagnostics Inc. Present in Europe in other categories | United States | CO2 Alkaline Buffer | K033061 (2003) |
| Diazyme Laboratories Present in Europe in other categories | United States | Diazyme | registered |
| FUJIFILM WAKO PURE CHEMICAL CORPORATION Present in Europe in other categories | Japan | Multi Calibrator Lipids | registered |
| Fisher Diagnostics | United States | Thermo Scientific Pacific Hemostasis® | K013397 (2002) |
| GOJJI, INC. | – | GOJJI BLOOD KETONE TEST STRIP | registered |
| Globalmed Holdings, LLC | United States | Smartest Persona II Multi Blood Glucose Monitoring System | registered |
| IDG/SANZAY Corporation | – | IDG/Sanzay | registered |
The 100 most active manufacturers are shown, out of 197.
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.
Related categories
- Urinary sediment devices8 manufacturers
- Limited panel chemistry analysers - other5 manufacturers
- Limited panel chemistry analysers - hardware accessories3 manufacturers
- Limited panel chemistry analysers - IVD medical device software2 manufacturers
- Blood-ammonia checkers1 manufacturer
- Parent category : Limited panel chemistry analysers41 manufacturers