Instruments for functional explorations and therapeutic interventions
Nephrology and haemodialysis instruments
EMDN code Z1209
Manufacturers registered in Europe (EUDAMED) 52
- 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) 114
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 |
|---|---|---|---|
| Guangzhou Daxin health technology Co.,Ltd | China | Body Composition Scale innotech truME Sealy Microlife FOXXD | registered |
| Nxstage Medical, Inc. | United States | NXSTAGE CARTRIDGE EXPRESS NXSTAGE SYSTEM ONE EXPRESS FLUID WARMER VersiHD EXPRESS FLUID WARMER DISPOSABLE VersiHD with GuideMe software | K232803 (2024) |
| Joicom Corporation | United States | RENPHO Body Composition Scale RENPHO Smart scale RENPHO RENPHO Body Fat Scale Fitindex RENPHO Mini Smart Body Fat Scale | registered |
| FRESENIUS MEDICAL CARE Present in Europe in other categories | Germany | FX CorAL Blood Pressure Cuff 5008X Top Tray Support plate 2008T BlueStar Hemodialysis Machine | K231534 (2024) |
| Vesync (US) Corporation | – | Etekcity Smart Fitness Scale Etekcity Etekcity WellFit™ Empower Smart Scale | registered |
| WITHINGS Present in Europe in other categories | France | Withings® Nokia | registered |
| Fresenius USA, Inc. | United States | 2008® Series Hemodialysis Machines Fresenius | K992275 (1999) |
| Shanghai May Skin Information Technology Co., Ltd. | China | MEICET | registered |
| Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. | – | Body Composition Scale Contact Health Eufy Wifi Smart Scale CoachCare innotech | registered |
| BEURER NORTH AMERICA, L.P. | – | Beurer Vitalcontrol InnoHaus | registered |
| R.J.L. SCIENCES, INC. | – | RJL Quantum BC | registered |
| InBody Co., Ltd. Present in Europe in other categories | South Korea | InBody | registered |
| Medica Corp. | United States | HPH-700TS HEMOCONCENTRAT HPH-1400 HEMOCONCENTRATOR HPH-700 HEMOCONCENTRATOR HPH JUNIOR HPH-1400TS HEMOCONCENTRATOR HPH-400TS HEMOCONCENTRATOR | K243920 (2025) |
| FKA DISTRIBUTING CO., LLC | – | Homedics | registered |
| GAMBRO INDUSTRIES | – | PRISMAFLEX SET | registered |
| Outset Medical, Inc. | United States | Tablo(R) Hemodialysis System TabloCart™ with Prefiltration Drawer Tablo Hemodialysis Console | K253412 (2026) |
| DASTMALCHI LLC | – | Vitagoods Vanity Planet My Life My Shop | registered |
| Dialco Medical Inc | Canada | SAMI Hemofiltration Cassette SAMI RRT Cassette DIMI RRT Cassette DIMI RRT System SAMI RRT System SAMI RRT | K193005 (2020) |
| Diality Inc | United States | Moda-flx Hemodialysis System | K233798 (2024) |
| Nuwellis Inc. | United States | Blood Circuit Set AquaFlexFlow UF 500 Plus - 24 Hr Aquadex SmartFlow Console AquaFlexFlow UF 500 Aquadex FlexFlow AquaFlexFlow UF 500 Plus | registered |
| Shenzhen Unique Scales Co., Ltd | China | Body composition analyzer | registered |
| Gambro Dialysatoren GmbH | – | REVACLEAR Polyflux | registered |
| LEXINGTON WELLNESS HOLDINGS INC. | – | Balance IdealSmart | registered |
| VIVE HEALTH LLC Present in Europe in other categories | United States | Vive VIVE PRECISION | registered |
| Zhongshan Transtek Electronics Co., Ltd. | China | medisana INSIGNIA EZFAST Transtek LIVING ENRICHMENT | registered |
| FondCircle Inc. | United States | FondCircle | registered |
| Gambro, Inc. | United States | Prismaflex MARS Monitor MARS TREATMENT KIT TYPE 1116/1 - X-MARS US | K083158 (2009) |
| Quanta Dialysis Technologies, Ltd. | United Kingdom | Dialysate Cartridge Quanta Dialysis System Bicarbonate Spare Connectors Set | K222067 (2022) |
| Star Elite Inc | Canada | Health O Meter | registered |
| TERUMO CORPORATION Present in Europe in other categories | United States | CAPIOX® HEMOCONCENTRATOR | registered |
| Fresenius Medical Care Renal Therapies Group, LLC | United States | 5008X Hemodialysis Machine Acid connector guide 1 Gal Acid connector cpl 10L jug | K261203 (2026) |
| I-Dialco Inc | Canada | SAMI Cassette SAMI RRT Unit DIMI RRT SYSTEM | registered |
| Shenzhen Yolanda Technology Co., Ltd. | China | arboleaf | registered |
| Sorin Group Italia S.R.L. Present in Europe in other categories | United States | DHF SH | K243264 (2025) |
| WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | – | CVS Health CVS | registered |
| Atflee | – | atflee | registered |
| Fitbit LLC Present in Europe in other categories | United States | Aria 2 Wi-Fi Smart Scale | registered |
| GOLDEN SMART HOME TECHNOLOGY CORP. | Taiwan | WowGoHealth Bluetooth Body Fat Analyzer WowGoHealth Body Fat Analyzer GSH202-B | registered |
| Gambro Renal Products | United States | REVACLEAR | K131516 (2014) |
| Guangdong Transtek Medical Electronics Co., Ltd. Present in Europe in other categories | China | Pulse TeleRPM | registered |
| LIDL US, LLC | – | Silvercrest | registered |
| LIVIN WELLNESS, LLC | – | LIVIN | registered |
| PARADIGM HEALTH & WELLNESS, INC. | – | MyCloudFitness Prevention | registered |
| QARDIO, INC. | United States | QardioBase 2 | registered |
| Shenzhen Witcaremed Medical Technology Co., Ltd | – | WITCAREMED | registered |
| TERRAILLON | – | TERRAILLON | registered |
| Teladoc Health, Inc. | United States | Teladoc Health, Inc. | registered |
| WALGREEN CO. | – | Walgreens WALGREEN | registered |
| Zhongshan Camry Electronic Co., Ltd. | China | BETTER HOMES AND GARDENS | registered |
| iHealth Labs Inc. | United States | iHealth | registered |
| Anhui Huami Healthcare Co.,Ltd. | – | Amazfit | registered |
| Anhui Huami Information Technology Co., Ltd. | China | Amazfit Balance | registered |
| ESCALI CORP | – | Escali | registered |
| GUANGDONG WELLAND TECHNOLOGY CO.,LTD | China | ABLEGRID | registered |
| Mozarc Medical US LLC Present in Europe in other categories | United States | CLEARUM HS | registered |
| Tenovi Co. | – | Tenovi | registered |
| VERIDIAN HEALTHCARE LLC | – | Zewa | registered |
| ARI Medical Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Andon Health Co, Ltd. Present in Europe in other categories | China | – | registered |
| Andon Medical Co., Ltd. | China | – | registered |
| Asahi Kasei Medical Co., Ltd. Present in Europe in other categories | United States | – | K162248 (2017) |
| Baxter Healthcare Corportation | United States | – | K201809 (2021) |
| Biotekna srl Present in Europe in other categories | Italy | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| Chf Solutions, Inc. | United States | – | K192756 (2020) |
| Conmo Electronic Company Limited | China | – | registered |
| Deka Research and Development | United States | – | K233557 (2024) |
| ETEKCITY COMPANY LIMITED | Macao SAR China | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| Fresenius Medical Care North America | United States | – | K162488 (2017) |
| Fresenius Medical Care Reanal Therapies Group, LLC | United States | – | K192928 (2020) |
| Guangdong Winburg Technology Co.,Ltd | China | – | registered |
| Guangdong Xinyu Electronic and Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| HEFEI MT MEDICAL CO.,LTD. Present in Europe in other categories | China | – | registered |
| Hian (Hong Kong) Co., Limited | Hong Kong SAR China | – | registered |
| IVUS ILAC SANAYI VE TICARET AS | Türkiye | – | registered |
| Infomed SA Present in Europe in other categories | Switzerland | – | registered |
| Jano Life Inc. | United States | – | registered |
| Kluge Design LLC | United States | – | registered |
| Krell Precision (Yang Zhou) Co., Ltd. | United States | – | registered |
| LIDER | France | – | registered |
| MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI | Türkiye | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| MuscleSound, Inc. | United States | – | registered |
| Nephros, Inc. | United States | – | K210575 (2022) |
| Ningbo Unico Products Co., Ltd Present in Europe in other categories | China | – | registered |
| Par Medizintechnik GmbH Present in Europe in other categories | Germany | – | registered |
| Pdi Works, LLC | United States | – | registered |
| Qinhuangdao Huisianpu Medical Systems Inc. Present in Europe in other categories | China | – | registered |
| Regent Electron Suzhou Co., Ltd | China | – | registered |
| SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI | Türkiye | – | registered |
| SARMED SRL | Italy | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Shanghai Youjoy Health Technology Co., Ltd. | China | – | registered |
| Shenzhen AOJ Medical Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| Shenzhen BelterHealthMeasurementAndAnalysisTechnology CoLtd | China | – | registered |
| Shenzhen Healthcare Electronic Technology Co., Ltd. | China | – | registered |
| Shenzhen Jumper Medical Equipment Co., Ltd. Present in Europe in other categories | China | – | registered |
| Shenzhen Ruiyi Business Technology Co., Ltd. | China | – | registered |
| Shenzhen Shine Industrial Co., Ltd. | China | – | registered |
The 100 most active manufacturers are shown, out of 114.
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