Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signsVital signs monitoring instruments
Blood pressure monitoring instruments
EMDN code Z12030203
Manufacturers registered in Europe (EUDAMED) 131
- 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) 537
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 |
|---|---|---|---|
| ICU MEDICAL, INC. Present in Europe in other categories | United States | Medex ICU Medical Transpac Portex Transpac™ Transpac™/Transtar™ | K070979 (2007) |
| Shenzhen Urion Technology Co., Ltd. Present in Europe in other categories | China | ALPHAMED AlphagoMed URION SDUNW | K254048 (2026) |
| ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. | – | Merit Medical® PT12(30CM) PT 84M(210CM) CRITIFLO(TM) TA1017M (3ML/HR) COMP PRLINE MF 100CM RED PT60M(150CM) | registered |
| American Diagnostic Corp. Present in Europe in other categories | United States | Diagnostix™ AdviewII™ E-Sphyg™ 3 Advantage™ E-Sphyg™ II Adview II | registered |
| Shenzhen Jamr Technology Co., Ltd. Present in Europe in other categories | China | Oklar Blood Pressure Monitor FOTOSY lovia cigii | K253570 (2026) |
| Boston Scientific Corp Present in Europe in other categories | United States | Direxion™ EkoSonic® Direxion™ HI-FLO™ EKOS™ + Direxion™ Fathom™-16 System Renegade™ HI-FLO™ | K260771 (2026) |
| AngioDynamics, Inc. | United States | PulseSpray UniFuse Uni-Fuse+ | registered |
| W. A. BAUM CO., INC. | United States | BAUM | registered |
| LUTECH INDUSTRIES INC Present in Europe in other categories | United States | Lutech | registered |
| Cook, Inc. | United States | CXI Cantata CrossCath TriForce Cook Slip-Cath | K182071 (2019) |
| VERIDIAN HEALTHCARE LLC | – | VERIDIAN Zewa SmartHeart Hello Heart Trackstar | registered |
| Micro Therapeutics, Inc. | United States | Rebar PhenomTM 17 Catheter RebarTM Echelon PhenomTM 27 Catheter MarksmanTM | K113289 (2012) |
| Summa Therapeutics, LLC | United States | Finesse BTK Multicath | registered |
| ZOLL Medical Corporation Present in Europe in other categories | United States | PROPAQ M ECG Tubing Hose Cable | K032363 (2003) |
| ATHENA GTX, INC. | United States | WVSM Wireless Vital Signs Monitor WVSM Pro, Wireless Vital Signs Monitor Professional Athena GTX Device Management Suite (ADMS) Software | registered |
| Joytech Healthcare Co. , Ltd. Present in Europe in other categories | China | SEJOY Maynovia LotFancy MEDLOT KOIOS | K261394 (2026) |
| NAVILYST MEDICAL, INC. | United States | NAMIC | registered |
| Shenzhen Pango Electronic Co., Ltd. | China | Electronic Blood Pressure Monitor | K200716 (2020) |
| Edan Instruments, Inc. Present in Europe in other categories | China | Patient Monitor Vital Signs Monitor Holter ECG and ABP System Ambulatory Blood Pressure Monitor RespArray | K210139 (2021) |
| Medos International Sàrl Present in Europe in other categories | Switzerland | PROWLER PROWLER SELECT RAPIDTRANSIT TRANSIT | K214025 (2022) |
| Microlife Corp. Present in Europe in other categories | United States | Microlife RITE AID ProCheck | K261082 (2026) |
| Health & Life Co., Ltd. | Taiwan | HoMEDICS Walgreens PRESTIGE | K211127 (2021) |
| HOPKINS UNIFORM COMPANY | – | Hopkins Medical Products® | registered |
| NEXSTEP MEDICAL | France | All'InCath 035M PTA Balloon Dilatation Catheter | registered |
| CENTURION MEDICAL PRODUCTS CORPORATION | United States | Centurion | K161408 (2016) |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Trulink Ontrak SPACELABS HEALTHCARE Ultraview SL Spacelabs | registered |
| Rudolf Riester GmbH & Co. KG | Germany | exacta® metal, black, obese size velcro cuff exacta® metal, black, adult size velcro cuff sanaphon® with stethoscope, child size velcro cuff pull through strap sphygmotensiophone manometer, without cuff ri-medic, Bluetooth®, wall mount, adult cuff and adult cuff obese, latex free exacta® metal, black, child size velcro cuff | K190927 (2019) |
| WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | – | CVSHealth CVS Health CVS | registered |
| Fukuda Denshi USA, Inc. Present in Europe in other categories | United States | FUKUDA DENSHI | K112521 (2011) |
| BEURER NORTH AMERICA, L.P. | – | Beurer Vitalcontrol InnoHaus | registered |
| Beijing Choice Electronic Technology Co., Ltd. Present in Europe in other categories | China | ChoiceMMed Mibest BLUE JAY | K162089 (2017) |
| Honsun (Nantong) Co., Ltd. | China | SCIAN Welby LotFancy E+R 中性 Dittmann | K262658 (2026) |
| TERUMO CORPORATION Present in Europe in other categories | United States | PROGREAT FINECROSS | registered |
| Inari Medical, Inc. Present in Europe in other categories | United States | Artix MT Artix AX Artix Thin-Walled Sheath Triever20 Artix™ AX ClotTriever BOLD Catheter | registered |
| Shenzhen AOJ Medical Technology Co., Ltd. Present in Europe in other categories | China | Medisana Electronic Blood Pressure Monitor DrBash Invaxe | K260276 (2026) |
| GE Healthcare Finland Oy Present in Europe in other categories | Finland | CARESCAPE CARESCAPE B850 CARESCAPE B450 CARESCAPE B650 CARESCAPE Software | registered |
| ARGON MEDICAL DEVICES, INC. | United States | Male/Female Luer Lock Plug Manifold Cardiac Output Bridge AHD Luer Lock Cap Double Male LL Adapter TRI-JECT 3-Way IV Administration Organizer without Stopcock | K223176 (2023) |
| Shenzhen Yuezhongxing Technology Co., Ltd. Present in Europe in other categories | China | Aleshon MMIZOO Safety Wercs Ronowee Aile | K233799 (2024) |
| Dongguan E-Test Technology Co., Ltd. | China | agelh | K250231 (2025) |
| WALGREEN CO. | – | Well at Walgreens Walgreens | registered |
| Avante | – | Waveline Pro+ Waveline EZ-MAX Waveline Touch+ Waveline VS | registered |
| FKA DISTRIBUTING CO., LLC | – | HOMEDICS Brookstone® | registered |
| Mediana Co., Ltd. Present in Europe in other categories | South Korea | Direct Supply Patient Monitor V10 | K200434 (2020) |
| Medtronic Care Management Services, LLC | United States | Commander Flex® Commander Commander Flex™ | K191745 (2020) |
| Concordance Healthcare Solutions LLC | – | HCS | registered |
| Dms Laboratories | United States | MABIS HealthSmart | registered |
| SUNMED, LLC Present in Europe in other categories | United States | Pulset Atellica® VTR Syringes A-Line | registered |
| Greater Goods | – | Greater Goods Balance | registered |
| Heine Optotechnik GmbH & Co. KG Present in Europe in other categories | Germany | HEINE GAMMA® HEINE GAMMA® G5 HEINE GAMMA® XXL LF HEINE GAMMA® G7 HEINE GAMMA® GP HEINE GAMMA® G5 Practice Kit | registered |
| Fudakang Industrial Co., Ltd. Present in Europe in other categories | China | AUPO FDK | K150430 (2015) |
| WAL-MART STORES, INC. | – | ReliOn Equate Member's Mark Equate 2 Plus ReliOn BP300W Wrist Blood Pressure Monitor Equate 1 Pro | registered |
| QARDIO, INC. | United States | QardioArm QardioArm2 Qardio Pro Cellular Blood Pressure Monitor | K220106 (2022) |
| iHealth Labs Inc. | United States | iHealth | registered |
| Airlife, Inc. | United States | AirLife™ | registered |
| Midmark Corp. Present in Europe in other categories | United States | Midmark Midmark IQvitals Device Kit w/touchscreen - Blood Pressure, Temperature and SpO2 Midmark IQvitals® Device Kit with touchscreen - Blood Pressure and Temperature Midmark IQvitals® Device with touchscreen - Blood Pressure, Temperature and SpO Midmark IQvitals® Device with touchscreen - Blood Pressure and Temperature | registered |
| Resource Optimization & Innovation, L.L.C. | – | Regard™ | registered |
| STRYKER CORPORATION Present in Europe in other categories | United States | Excelsior 1018 EXCELSIOR XT-27 Flex EXCELSIOR XT-27 Trevo | registered |
| Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. | – | cofoe biotricity koogeek B WELL eocene | registered |
| Becton, Dickinson & CO Present in Europe in other categories | United States | Acumen IQ Acumen IQ, VAMP TruWave, VAMP Plus TruWave SWAN-GANZ CCOMBO V VAMP | registered |
| Sotera Wireless, Inc. | United States | ViSi | registered |
| CRITICARE TECHNOLOGIES, INC. | United States | Criticare Criticare Gemini | registered |
| MCKESSON CORPORATION | United States | Foster & Thrive Health Mart Sunmark | registered |
| Sejoy Biomedical Co.,Ltd. Present in Europe in other categories | China | LotFancy WELBY REIZEN | registered |
| Shenzhen Changkun Technology Co., Ltd. Present in Europe in other categories | China | MBUPAI Coverich NOUYAN MMIZOO Wishlove maguja | K193386 (2021) |
| VIVE HEALTH LLC Present in Europe in other categories | United States | Vive Precision VIVE VIVE HEALTH | registered |
| WESTMED, INC. | United States | Pulset Blood Gas Sampler Full Kit Pulset™, 1cc Syringe 25g x 5/8" Crickett™ ˜25u BH Pulset™ 3cc Syringe 23g x 1" Safety Tip™ ˜25u BH (0.6 x 25mm) | registered |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| Cardinal Health 110, Inc. | – | LEADER | registered |
| Innova Vascular, Inc. | United States | Malibu Aspiration Catheter System Laguna Clot Retriever System | registered |
| Tenovi Co. | – | Tenovi | registered |
| Vesalio | United States | pVasc Aspiration Catheter 70, 132 cm NeVa pVasc 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 180 cm wire System pVasc Aspiration Catheter 70, 125 cm NeVa pVasc 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 180 cm wire System pVasc Aspiration Catheter 70, 140 cm enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wire | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED PATIENT MONITOR ADVANCED VITAL SIGNS MONITOR | registered |
| Ageless Health Industrial Co., Ltd. | China | AGE | K172895 (2018) |
| Joicom Corporation | United States | RENPHO Blood Pressure Monitor RENPHO Smart Blood Pressure Monitor renpho RENPHO Automatic Blood Pressure Monitor | registered |
| MEIJER, INC. | – | Meijer | registered |
| D. E. Hokanson, Inc. Present in Europe in other categories | United States | Hokanson | K905367 (1991) |
| EASY HEALTHCARE CORPORATION | – | Easy@Home Blood Pressure Monitor Easy@Home Wrist Blood Pressure Monitor Easy@Home Arm Blood Pressure Monitor Easy@Home Arm-type Fully Automatic Digital Blood Pressure Monitor | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | B125M CARESCAPE ONE B155M Portrait VSM B105M | K911310 (1991) |
| Masena Invest B.V. | Netherlands | iProvèn iPovèn | registered |
| Sevenground Trading B.V. | Netherlands | iProven iProvèn Keenhealth | registered |
| Balt USA, LLC Present in Europe in other categories | United States | Magic Infusion Catheter | K213435 (2022) |
| Bioland Technology, Ltd. Present in Europe in other categories | China | bioland INSMART COLEBY Sibel | K202934 (2021) |
| H. E. BUTT GROCERY COMPANY | – | HEB in Control | registered |
| PUBLIX SUPER MARKETS, INC. | – | Publix - Wrist BPM Publix Publix - Deluxe BPM Publix - BPM Publix - Automatic BPM Publix - Dual Memory BPM | registered |
| STRATEGIC SOURCING SERVICES LLC | – | sunmark HealthMart | registered |
| THROMBOLEX, INC. | United States | Bashir™ Endovascular Catheter Bashir™ S-B Endovascular Catheter 7Fr, 10.0cm basket Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 30.0cm Infusion Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion Bashir™ N-X Endovascular Catheter Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 40.0cm Infusion | registered |
| Expanse Medical, Inc. | 94566 | FLOWRUNNER 12F Aspiration System, 100cm FLOWRUNNER 12F Aspiration System, 120cm FLOWRUNNER 12F Aspiration System, 80cm FLOWRUNNER SP 7F Aspiration System, 130cm FLOWRUNNER 14F Aspiration System, 100cm FLOWRUNNER 14F Aspiration System, 120cm | registered |
| HOME AIDE DIAGNOSTICS, INC. | – | True Health Sense Blood Pressure Monitor Pro Health Mini: Talking Blood Pressure Monitor Talking Sense Upper Arm Blood Pressure Monitor Health Sense Upper Arm Blood Pressure Monitor Health Sense Upper Arm Blood Pressure Monitor XL cuff Talking Sense Upper Arm Blood Pressure Monitor XL cuff | registered |
| Hetaida Technology Co., Ltd. Present in Europe in other categories | China | Hetaida CARE VISION LPOW | K243661 (2025) |
| NUVOMED, INC. | – | NuvoMed | registered |
| SILEX GLOBAL LLC | – | PARAMED | registered |
| SIMPLE DIAGNOSTICS INC | United States | Clever Choice | registered |
| Shenzhen HanHan Technology Co., Ltd | China | Arm Blood Pressure Monitor | K254225 (2026) |
| Shenzhen Lingku Ecommerce Co., Ltd. | – | Metene CKeep FANRY LPOW ANKOVO | registered |
| Thermor Ltd | Canada | BIOS Diagnostics BIOS | K122810 (2013) |
| AV MEDICAL TECHNOLOGIES LTD | – | Chameleon | registered |
| DARIOHEALTH CORP. | – | Dario Blood Pressure Monitoring System (M cuff) Dario Blood Pressure Monitoring System (Large cuff) Dario Smart Blood Pressure Monitor Gen 2 Dario Smart Monitor (Cellular)- Blood Pressure Monitoring System Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System | registered |
| DIABETIC SUPPLY OF SUNCOAST, INC. | – | Advocate Blood Pressure Monitor Non-Speaking Wrist Advocate Blood Pressure Monitor, Wrist, Model SPBP-02, Bilingual Advocate Arm BPM S/M CUFF American Heart- Tech Non-Speaking Wrist BPM Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff Advocate Wrist BPM W/Color Indicator | registered |
| InBody Co., Ltd. Present in Europe in other categories | South Korea | InBody | K231174 (2023) |
| Intervene, Inc. | United States | Recana Introducer Sheath, 16Fr x 90cm Recana Introducer Sheath, 13Fr x 90cm Recana Debulking Catheter Recana Collection Basket, 30mm Recana Introducer Sheath, 13Fr x 30cm Recana Introducer Sheath, 16Fr x 30cm | registered |
The 100 most active manufacturers are shown, out of 537.
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