IVD instrumentsChemistry / immunochemistry instruments
Blood gas analysis / electrolyte instruments
EMDN code W020104
Manufacturers registered in Europe (EUDAMED) 33
- 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 |
|---|---|---|---|---|
| Eschweiler | Germany | – 98/79 | Website info@eschweiler-kiel.de EUDAMED record Report an error | |
| Cornley EU representative : Caretechion GmbH (Germany) and 1 other | China |
2 others
|
A IVDR, 98/79 | Website sales@cornley.com EUDAMED record Report an error |
| Instrumentation Laboratory FDA EU representative : Instrumentation Laboratory SpA (Italy) | United States | A IVDR | Website Regulatory@werfen.com EUDAMED record Report an error | |
| Seamaty EU representative : MedNet EC-REP GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Diamond Diagnostics FDA EU representative : Diamond Diagnostics Inc. Magyarországi Fióktelepe (Hungary) | United States | A IVDR | Website EUDAMED record Report an error | |
| Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | A IVDR, 98/79 | EUDAMED record Report an error | |
| i-SENS FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | South Korea | A IVDR | Website regulatory@i-sens.com 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 | |
| ZOVEC diagnostics | Germany | – 98/79 | Website 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 | |
| BioFynder EU representative : SUNGO Europe B.V. (Netherlands) | United Kingdom (ex Northern Ireland) | A IVDR | EUDAMED record Report an error | |
| Eaglenos FDA EU representative : MedPath GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Human | Germany | A IVDR | Website EUDAMED record Report an error | |
| Optimedical FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | 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 | |
| Wondfo FDA EU representative : QbD RepS BV (Belgium) | China | A IVDR | Website sales@wondfo.com.cn EUDAMED record Report an error | |
| Accriva Diagnostics FDA EU representative : MDSS GmbH (Germany) | United States | – 98/79 | Website EUDAMED record Report an error | |
| B&E Bio-Technology FDA EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| ElitechGroup FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) | United States |
|
– 98/79 | Website info@elitechgroup.com EUDAMED record Report an error |
| Erba | Czechia | A IVDR | Website EUDAMED record Report an error | |
| EXIAS Medical | Austria | A IVDR | Website office@exias-medical.com EUDAMED record Report an error | |
| Genrui Biotech FDA EU representative : Lotus NL B.V. (Netherlands) | China |
|
– 98/79 | Website service@genrui-bio.com EUDAMED record Report an error |
| Jokoh EU representative : MDSS GmbH (Germany) | Japan |
|
A IVDR | Website EUDAMED record Report an error |
| JS Medicina Electrónica EU representative : CMC Medical Devices & Drugs SL (Spain) | Argentina |
|
A IVDR | Website info@diestroweb.com EUDAMED record Report an error |
| Medconn FDA EU representative : JOYSUN GROUP S.L.U (Spain) | China | A IVDR | EUDAMED record Report an error | |
| Medicacorp EU representative : Emergo Europe B.V. (Netherlands) | United States | B IVDR | Website EUDAMED record Report an error | |
| Poweam EU representative : SUNGO Europe B.V. (Netherlands) | China | A IVDR | EUDAMED record Report an error | |
| Pushkang EU representative : Sungo Cert GmbH (Germany) | China | A IVDR | EUDAMED record Report an error | |
| Radiometer FDA | Denmark | A IVDR | Website radiometerra_eu@radiometer.dk EUDAMED record Report an error | |
| Sensacore EU representative : Obelis s.a. (Belgium) | India | A IVDR | Website EUDAMED record Report an error | |
| Utsat | Türkiye | A IVDR | Website info@utsat.com.tr EUDAMED record Report an error | |
| Ns Biotec EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market | Egypt |
|
– 98/79 | Website info@nsbiotec.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) 155
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 |
|---|---|---|---|
| Nova Biomedical Corp. | United States | STAT PROFILE NOVA NOVA/STAT PROFILE StatSensor/StatStrip STATSTRIP | K221900 (2023) |
| Epocal Inc Present in Europe in other categories | Canada | EPOC READER EPOC HOST, RX, REFURB EPOC BGEM TEST CARD EPOC BGEM CREA TEST CARD HOST 2, EPOC EPOC HOST, CA, REFURBISHED | K200107 (2020) |
| Abbott Point of Care, Inc. Present in Europe in other categories | United States | i-STAT i-STAT G Cartridge i-STAT G3+ Cartridge | K244014 (2025) |
| Medica Corp. | United States | pH/pCO2/pO2/Na/K/Ca Analyzer Na/K/Ca/pH Solution Pack Bi-Level QC Kit, HCT Reagent Module Daily Cleaning Solution Kit ISE Reagent Pack | K220328 (2024) |
| Shenzhen Yuwen E-Commerce Co., Ltd. | China | AUVON | registered |
| YSI INCORPORATED | United States | YSI Incorporated | K210933 (2024) |
| PHILOSYS Co., Ltd | United States | Gmate® STEP Blood Glucose Monitoring System Gmate® VOICE Blood Glucose Monitoring System Gmate® Origin Blood Glucose Monitoring System Gmate® mini Blood Glucose Monitoring System GlucoTrack SMART Blood Glucose Monitoring System Gmate® SMART Blood Glucose Monitoring System | K113636 (2013) |
| ACON Laboratories, Inc. | United States | On Call Vivid Blood Glucose Test Strips On Call Plus Blood Glucose Test Strips On Call Pro Blood Glucose Test Strips On Call Express Blood Glucose Test Strips On Call Express Voice Blood Glucose Monitoring System On Call Plus Blood Glucose Monitoring System | K122553 (2013) |
| POLYMER TECHNOLOGY SYSTEMS, INC. | United States | CardioChek® Plus Professional Analyzer CardioChek Plus Home Self-Test Analyzer CardioChek Plus Lipid + eGLU Test Strips Smart Bundle™ (2-pk) CardioChek® PA analyzer PTS Panels® CHOL+Glu Test Strips PTS Panels® CHOL+HDL+GLU Test Strips (10-ct) | K151530 (2015) |
| Hemocue AB Present in Europe in other categories | United States | HemoCue® Glucose 201 Microcuvettes HemoCue® Glucose 201 Analyzer HemoCue® Hb 301 Microcuvettes HemoCue® Hb 201 Microcuvettes HemoCue® Hb 201+ Analyzer HemoCue® Hb 201 DM Analyzer | K201217 (2020) |
| BIONIME CORPORATION Present in Europe in other categories | United States | GE Rightest ODM | registered |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | Accutrend Plus Meter Kit cobas b 221 GLU Cassette Accutrend Glucose Test Strips PO2 Electrode PCO2 Electrode pH Electrode | K111188 (2012) |
| Prodigy Diabetes Care, LLC | – | Prodigy No Coding Blood Glucose Test Strips Prodigy AutoCode Blood Glucose Monitoring System Prodigy Pocket Blood Glucose Monitoring System Prodigy Voice Blood Glucose Monitoring System Prodigy iConnect Blood Glucose Monitoring System PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips | registered |
| Abbott Laboratories Present in Europe in other categories | United States | ARCHITECT Alinity | K170320 (2017) |
| BIOTEST MEDICAL CORPORATION | – | Oracle Perfect 3 Smartest PersonaII B T M | registered |
| FORA CARE INC. Present in Europe in other categories | Taiwan | FORA | K121706 (2013) |
| Randox Laboratories, Ltd. Present in Europe in other categories | United Kingdom | GLUC-PAP L-LACTATE (LAC) I.S.E. CL I.S.E. REF | K024014 (2003) |
| WAL-MART STORES, INC. | – | ReliOn™ Premier Blood Glucose Test Strips Members Mark ReliOn® Prime Blood Glucose Test Strips ReliOn® Confirm/micro Blood Glucose Test Strips ReliOn™ Premier Voice Basic Meter ReliOn™ Premier Classic Meter | registered |
| ABAXIS, INC. Present in Europe in other categories | United States | Piccolo Renal Function Panel Piccolo General Chemistry 6 Piccolo Lipid Panel Plus Piccolo Comprehensive Metabolic Panel Piccolo AmLyte 13 Piccolo BioChemistry Panel Plus | K130113 (2013) |
| HORIBA INSTRUMENTS INCORPORATED | United States | Pointe Scientific, Inc. Pointe Scientific, Inc. Glucose Ox Pointe Scientific, Inc. Glucose Hex Pointe Scientific, Inc. Glucose Standard Pointe Scientific, Inc. Glucose Oxidase | registered |
| INFRARED LABORATORY SYSTEMS LLC | United States | Synermed® | registered |
| Lifehealth | – | CC Cartridge H3 Cartridge GL Cartridge BG Cartridge LA Cartridge H4 Cartridge | registered |
| TECO DIAGNOSTICS | United States | Teco Diagnostics TC Matrix Clinical Chemistry Analyzer Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set Teco Diagnostics Glucose (Oxidase) Reagent Set Teco Diagnostics Glucopad Blood Glucose Test Strips TECO DIAGNOSTICS Teco Diagnostics Glucose (Oxidase) Liquid Reagent Set for TC Matrix | registered |
| TYSON BIORESEARCH INC. Present in Europe in other categories | Taiwan | TysonBio AC500 PRO Blood Glucose Test Strips (50T) TysonBio AC200 Blood Glucose Test Strips (50T) TysonBio AC200 Blood Glucose Monitoring System Tyson Bio AC500 PRO Control Solution (Level 3) (FDA) TysonBio EVOLVE Blood Glucose Monitoring System TysonBio AC200 Blood Glucose Test Strips (25T) | registered |
| CAROLINA LIQUID CHEMISTRIES CORPORATION | United States | ISE ELECTROLYTE BUFFEER REAGENT KIT 88810 CLC6410 Chemistry Analyzer with or without ISE ISE ELECTROLYTE REFERENCE 88811 CLC1600 Chemistry Analyzer with ISE Module CLC800 Chemistry Analyzer with ISE Module Carolina Liquid Chemistries Corp. ISE Reference Solution DT88811 | registered |
| DREW SCIENTIFIC, INC. | United Kingdom | JAS Diagnostics | K070704 (2007) |
| LABSTYLE INNOVATION LTD | – | Dario® USB-C Blood Glucose Monitoring System - Starter Kit 50 Dario Blood Glucose Test Strip Dario LC Blood Glucose Monitoring System & Dario Membership 100 Blood Glucose Test Strip 25 Blood Glucose Test Strip Dario 300 Test Strips Bundle | registered |
| HMD BIOMEDICAL INC. Present in Europe in other categories | – | GlucoLeader Enhance Blood Glucose vial packed test strip GlucoLeader Enhance Blood Glucose Monitoring System GlucoLeader Enhance Blood Glucose Test Strip GlucoLeader Enhance Blood Glucose Test Strip(for PTA) GlucoLeader Enhance Blood Glucose foil packed test strip GlucoLeader Enhance Blood Glucose Test Strip(for AF-SSA) | registered |
| TRIVIDIA HEALTH, INC. | United States | TRUEtrack TRUEbalance | registered |
| U. S. Diagnostics, Inc. | United States | INFINITY™ Starter Kit EasyGluco™G2 Test Strips Easygluco® Plus Test Strips INFINITY™ Meter Kit EasyGluco™G2 Starter Kit Control™ Meter Kit | K061431 (2007) |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | CardioChek Henry Schein | registered |
| Phoenix Diagnostics, Inc. | United States | Phoenix Diagnostics PHOENIX DIAGNOSTICS, INC. | K020148 (2002) |
| Lifescan, Inc. Present in Europe in other categories | United States | OneTouch Ultra Blue OneTouch Ultra2 OneTouch Ultra OneTouch Ultra Blue Test Strips | K043197 (2005) |
| OK BIOTECH CO., LTD. Present in Europe in other categories | Taiwan | TruePoint Smartest Persona II Multi Blood Glucose Monitoring System Perfect 3 Multi Blood Glucose Test Strips | registered |
| STANBIO LABORATORY, L.P. | United States | Glucose LiquiColor® Glucose Standard (100 mg/dL) n•x•t Microcuvette HemoPoint® H2 n•x•t Microcuvettes HemoPoint H2 ISE Chloride Electrode | K090093 (2009) |
| Cardinal Health 110, Inc. | – | LEADER | registered |
| Ekf-Diagnostic GmbH Present in Europe in other categories | Germany | DiaSpect Tm Hemo Control DiaSpect Tm Cuvettes Cleaner Hemo Control Hemoglobin Microcuvette Add Pack Hemo Control DM | K200909 (2020) |
| KPI HEALTHCARE, INC. | – | CURO A1c Curo L5 Curo A1c Analyzer CURO L5 Total Cholesterol Strips | registered |
| LIVONGO HEALTH, INC | – | Livongo Refill Kit Livongo Health, Inc. by Teladoc Health, Inc. Livongo Welcome Kit Livongo Test Strips Livongo Test Strips - Mexico | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| Medtronic Minimed Present in Europe in other categories | United States | Enlite™ Serter CGMS® iPro™ GUARDIAN® MiniLink® REAL-Time Enlite® Serter Medtronic Guardian™ Link | registered |
| PHARMA TECH SOLUTIONS, INC. | – | GenUltimate Zephyr! Alltara Zephyr! GenUltimate! GenUltimate | registered |
| Tianjin Empecs Medical Device Co.,Ltd Present in Europe in other categories | China | CareTouch Medisign | registered |
| Care Living Diagnostics Inc. | United States | CareLiving MM1100 Blood Glucose Test Strips 50ct CareLiving BGM101 Blood Glucose Meter CareLiving MM1100 Blood Glucose Test Strips 100ct CareLiving MM1100 Blood Glucose Monitoring System CareLiving Blood Glucose Test Strips 50ct CareLiving Blood Glucose Test Strips 100ct | registered |
| GERMAINE LABORATORIES, INC | United States | AimStrip Tandem Lipid Profile and glucose measuring system AimStrip Tandem blood glucose test strips AIMSTRIP PLUS, BLOOD GLUCOSE TEST STRIPS AIMSTRIP Hb ADAPTOR AIMSTRIP HEMOGLOBIN TEST CARTRIDGES AIMSTRIP HEMOGLOBIN METER | registered |
| Ortho-Clinical Diagnostics, Inc. Present in Europe in other categories | United States | VITROS | K190520 (2019) |
| SD Biosensor, Inc. Present in Europe in other categories | South Korea | SD GlucoNavii Blood Glucose Monitoring System SD GlucoNavii Blood Glucose Test Strip SD Glucose Control Solution | registered |
| Teladoc Health, Inc. | United States | Teladoc Health, Inc. | registered |
| UAN HEALTHCARE LIMITED | – | AUVON | registered |
| Alere San Diego, Inc. Present in Europe in other categories | United States | Cholestech LDX™ Alere Cholestech LDX® | K223179 (2023) |
| HOME AIDE DIAGNOSTICS, INC. | – | Easy Plus II Blood Glucose Testing Strips 25ct Easy Talk/Plus II Glucose Test Strips Easy Trak Blood Glucose Test Strips 25ct Easy Step Blood Glucose Test Strips 50ct Easy Talk Blood Glucose Testing Strips 25ct | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline MEDLINE INDUSTRIES | registered |
| METENE LIMITED | United States | metene Blood Glucose Test Strips (50pcs*2) ANKOVO TD-4267 Blood Glucose Test Strips 100PCS metene Blood Glucose Test Strips (50pcs*6) ANKOVO TD-4267 BLOOD GLUCOSE MONITORING SYSTEM | registered |
| OMNIS HEALTH, LLC | – | EmbraceWAVE Blood Glucose Test Strips 25 ct. EmbraceWAVE+ Blood Glucose Monitoring System Value Pack EmbraceWAVE Blood Glucose Test Strips 100 ct. EmbraceWAVE+ Blood Glucose Monitoring System Starter Kit EmbraceWAVE Blood Glucose Test Strips 50 ct. | registered |
| Immunostics Company, Inc | United States | hemochroma PLUS Starter Kit hemochroma PLUS Microcuvettes hemochroma PLUS Analyzer hemochroma PLUS Optical System Check | K182298 (2018) |
| OSANG HEALTHCARE Co., Ltd. Present in Europe in other categories | South Korea | Element™ Test Strips Element™Plus Meter Element™ Meter Element™Plus Test Strips | registered |
| VALUE PROVIDERS LLC | – | Eocene Smart Diabetes | registered |
| VISGENEER, INC. Present in Europe in other categories | Taiwan | eBcarryon eBsensor | registered |
| ABOUND Diagnostics, Inc. | – | VivaGuard Ino Smart Blood Glucose Meter VivaGuard Ino Blood Glucose Test Strips VivaGuard Ino Blood Glucose Meter | registered |
| Apex BioTechnology Corp. Present in Europe in other categories | Taiwan | THE EDGE Lactate Control Solution THE EDGE Blood Lactate Test Strip (non-sterile) THE EDGE Blood Lactate Monitoring System | K142689 (2015) |
| Biobase Biodustry(Shandong)Co., Ltd. | China | BIOBASE | registered |
| HORIBA ABX SAS Present in Europe in other categories | France | ABX PENTRA CHLORIDE-E Yumizen C1200 Lactate ABX PENTRA LACTIC ACID | registered |
| HUDSON SCIENTIFIC, LLC | United States | D-Care | registered |
| Hearts Bio, Inc. | – | HeartsCare LACTATE TEST STRIPS (25PCS/BOX) HeartsCare LACTATE TEST STRIPS (10PCS/BOX) HeartsCare C1 LACTATE TEST STRIPS (10PCS/BOX) | registered |
| Ideal Life Inc | United States | IDEAL LIFE Blood Glucose Test Strips 1 vial of 25 Test Strips IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips) IDEAL LIFE Control Solution Level II | registered |
| MEDSOURCE INTERNATIONAL LLC | – | MedSource Glucometer Test Solution (Normal, high) MedSource Glucose Meter, DS-A MedSource Glucometer Test Strips, DS-A | registered |
| MHC MEDICAL PRODUCTS, LLC | – | EasyTouch BluLink | registered |
| Able Diagnostics Inc | – | VivaGuard Ino | registered |
| Beckman Coulter, Inc. Present in Europe in other categories | United States | Synchron AU | K103842 (2011) |
| HEPRO.US INC. Present in Europe in other categories | – | HEPRO.US MM1000 Blood Glucose Monitoring System Kit HEPRO.US MM1000 BRAND CT40 GLUCOSEMETER KIT - | registered |
| JANT PHARMACAL CORPORATION | – | LipidPlus® Meter LipidPlus® Glucose Test Strips | registered |
| LEXINGTON WELLNESS HOLDINGS INC. | – | Scan | registered |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories | China | Chemistry Analyzer Cl electrode,indirect,international | registered |
| Unistrip Technologies, LLC | – | UniStrip1 Generic Blood Glucose Test Strip Equate Blood Glucose Test Strips | registered |
| VERTEX DIAGNOSTICS LLC | – | UltraTRAK TM 50 Test Strips UltraTRAK Complete 50 Test Strips | registered |
| ALFA WASSERMANN, INC. | United States | Alfa Wassermann | registered |
| ANDESFIT LIMITED | – | Andnesfit Health | registered |
| Awareness Technology, Inc. | United States | SelectaLyte (Chloride Electrode) | registered |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| BTNX Inc | – | Rapid Response | registered |
| CHEMATICS, INC. | United States | Chemcard Glucose | registered |
| DiaSpect Medical GmbH Present in Europe in other categories | – | DiaSpect Hemoglobin Cuvettes | registered |
| FORACARE TEXAS, INC | – | Pro Voice | registered |
| FUTURE DIAGNOSTICS LLC | – | Care Touch | registered |
| Globalmed Holdings, LLC | United States | Smartest Persona II Multi Blood Glucose Monitoring System | registered |
| Greater Goods | – | Greater Goods | registered |
| H. E. BUTT GROCERY COMPANY | – | H-E-B inControl | registered |
| JEOL LTD. | Japan | Chloride Electrode | registered |
| RITE AID CORPORATION | – | Rite Aid Pharmacy | registered |
| SIMPLE DIAGNOSTICS INC | United States | Clever Choice | K120921 (2012) |
| Syntron Bioresearch, Inc. | United States | Glucose Pilot | registered |
| TELCARE, LLC | – | BioTel Care® Test Strips | registered |
| TOKYO BOEKI MEDISYS INC. | United States | Cl (Chloride) Electrode | registered |
| VISIOMED GROUP | France | BEWELL CONNECT MyGluco | registered |
| WALGREEN CO. | – | Walgreens | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| ARKRAY Industry West,Inc. | Philippines | – | registered |
| AVE Science & Technology Co., Ltd Present in Europe in other categories | China | – | registered |
| AgaMatrix, Inc. | United States | – | registered |
| Alliance Medical Corp. | United States | – | registered |
The 100 most active manufacturers are shown, out of 155.
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