Instruments for functional explorations and therapeutic interventionsNephrology and haemodialysis instruments
Haemodialysis instruments
EMDN code Z120902
Manufacturers registered in Europe (EUDAMED) 12
- 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 |
|---|---|---|---|---|
| SWS Hemodialysis Care EU representative : MedPath GmbH (Germany) | China | IIb MDR, 93/42 | EUDAMED record Report an error | |
| Bbraun FDA | Germany |
|
IIb MDR | Website eudamed@bbraun.com EUDAMED record Report an error |
| Advitos | Germany | IIb MDR | Website info@advitos.com EUDAMED record Report an error | |
| Nikkiso FDA EU representative : NIKKISO Medical Europe GmbH (Germany) | Japan |
|
IIb MDR, 93/42 | EUDAMED record Report an error |
| Nipro FDA EU representative : Nipro Medical Europe NV (Belgium) | Japan |
|
IIb 93/42 | EUDAMED record Report an error |
| Guangdong Biolight Meditech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIb MDR | Website EUDAMED record Report an error | |
| Guangzhou Oci Medical Devices EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) | China | IIb MDR | EUDAMED record Report an error | |
| Guangzhou Phoenix Medical Equipment EU representative : MedNet EC-REP C IIb GmbH (Germany) | China | IIb MDR | EUDAMED record Report an error | |
| IBD Italian Biomedical Devices | Italy | IIb MDR | info@ibdsrl.com EUDAMED record Report an error | |
| Physidia | France | IIb 93/42 | Website EUDAMED record Report an error | |
| Vantive FDA EU representative : Vantive S.r.l. (Italy) | Switzerland |
|
IIb MDR | Website EUDAMED record Report an error |
| Renalyx EU representative : Amstermed B.V. (Netherlands) No model still on the market | India |
|
IIb 93/42 | 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) 44
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 |
|---|---|---|---|
| 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) |
| 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) |
| Fresenius USA, Inc. | United States | 2008® Series Hemodialysis Machines Fresenius | K992275 (1999) |
| Medica Corp. | United States | HPH-700TS HEMOCONCENTRAT HPH-1400 HEMOCONCENTRATOR HPH-700 HEMOCONCENTRATOR HPH JUNIOR HPH-1400TS HEMOCONCENTRATOR HPH-400TS HEMOCONCENTRATOR | K243920 (2025) |
| GAMBRO INDUSTRIES | – | PRISMAFLEX SET | registered |
| Outset Medical, Inc. | United States | Tablo(R) Hemodialysis System TabloCart™ with Prefiltration Drawer Tablo Hemodialysis Console | K253412 (2026) |
| 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 |
| Baxter Healthcare Corp Present in Europe in other categories | United States | therMaxTherMax Blood Warmer prisMaxPrisMax System Revaclear | K232467 (2023) |
| Bellco Srl Present in Europe in other categories | Italy | CLEARUM HS | K231406 (2023) |
| Gambro Dialysatoren GmbH | – | REVACLEAR Polyflux | 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) |
| 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 |
| Sorin Group Italia S.R.L. Present in Europe in other categories | United States | DHF SH | K243264 (2025) |
| Gambro Renal Products | United States | REVACLEAR | K131516 (2014) |
| Mozarc Medical US LLC Present in Europe in other categories | United States | CLEARUM HS | registered |
| Asahi Kasei Medical Co., Ltd. Present in Europe in other categories | United States | – | K162248 (2017) |
| Baxter Healthcare Corportation | United States | – | K201809 (2021) |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| Chf Solutions, Inc. | United States | – | K192756 (2020) |
| Deka Research and Development | United States | – | K233557 (2024) |
| 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) |
| IVUS ILAC SANAYI VE TICARET AS | Türkiye | – | registered |
| Infomed SA Present in Europe in other categories | Switzerland | – | registered |
| Kluge Design LLC | United States | – | registered |
| LIDER | France | – | registered |
| MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI | Türkiye | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| Nephros, Inc. | United States | – | K210575 (2022) |
| Par Medizintechnik GmbH Present in Europe in other categories | Germany | – | registered |
| SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI | Türkiye | – | registered |
| SARMED SRL | Italy | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Spectral Medical Inc Present in Europe in other categories | Canada | – | K170790 (2017) |
| Tecnoideal America | United States | – | K232171 (2024) |
| Terumo Medical Corp. Present in Europe in other categories | United States | – | K013550 (2001) |
| Valmed Corp. | United States | – | registered |
| Worldwide Supplies Limited | Hong Kong SAR China | – | registered |
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