Instruments to support and monitor vital signsVital signs monitoring instrumentsBlood pressure monitoring instruments
Invasive blood pressure monitoring instruments
EMDN code Z1203020301
Manufacturers registered in Europe (EUDAMED) 32
- 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) 152
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) |
| 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 |
| Cook, Inc. | United States | CXI Cantata CrossCath TriForce Cook Slip-Cath | K182071 (2019) |
| BIOPTIMAL INTERNATIONAL PTE. LTD. Present in Europe in other categories | Singapore | BIOTRANS™ Pressure Monitoring Kits BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables ACCUTRANS Disposable Pressure Monitoring Kit ACCUTRANS™ Disposable Pressure Monitoring System | registered |
| 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 |
| 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 |
| NAVILYST MEDICAL, INC. | United States | NAMIC | registered |
| Medos International Sàrl Present in Europe in other categories | Switzerland | PROWLER PROWLER SELECT RAPIDTRANSIT TRANSIT | K214025 (2022) |
| NEXSTEP MEDICAL | France | All'InCath 035M PTA Balloon Dilatation Catheter | registered |
| CENTURION MEDICAL PRODUCTS CORPORATION | United States | Centurion | K161408 (2016) |
| 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 |
| 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) |
| SUNMED, LLC Present in Europe in other categories | United States | Pulset Atellica® VTR Syringes A-Line | registered |
| Airlife, Inc. | United States | AirLife™ | 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 |
| 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 |
| 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 |
| Innova Vascular, Inc. | United States | Malibu Aspiration Catheter System Laguna Clot Retriever System | 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 |
| Balt USA, LLC Present in Europe in other categories | United States | Magic Infusion Catheter | K213435 (2022) |
| 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 |
| AV MEDICAL TECHNOLOGIES LTD | – | Chameleon | registered |
| 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 |
| MicroVention, Inc. | United States | VIA Microcatheter PG PRO | registered |
| Mozarc Medical US LLC Present in Europe in other categories | United States | Chameleon | registered |
| Instylla, Inc. | United States | Instylla Microcatheter Instylla Microcatheter 1.2 | K261610 (2026) |
| Mercator Medsystems, Inc. | United States | Bullfrog Micro-Infusion Device LEAPFROG Micro-Infusion Device | K210339 (2021) |
| St Jude Medical | United States | PressureWire™ | K161171 (2016) |
| TERUMO CLINICAL SUPPLY CO., LTD. | Japan | Progreat Lambda | registered |
| ENDOPHYS HOLDINGS, LLC | United States | Endophys Pressure Sensing Sheath Kit - 8F 25 CM Endophys Pressure Sensing Sheath Kit - 6F 12 CM Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No Guidewire Endophys Pressure Sensing Sheath Kit - 6F 12 CM, No Guidewire Endophys Pressure Sensing Sheath Kit - 8F 11 CM | registered |
| IMPERATIVE CARE, INC. | United States | Symphony™ Catheter Symphony™ Clot Container Symphony™ Advance™ Long Dilator Symphony™ 16F 82cm Catheter | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | PILLING | registered |
| Agile Devices, Inc. | United States | Agile Angler | K211110 (2022) |
| SEQUENT MEDICAL, INC. | United States | VIA Microcatheter | K123477 (2013) |
| SUREFIRE MEDICAL, INC. | – | TriNav XP Infusion System TriNav LV Infusion System | registered |
| Volcarica S.R.L. | – | Verrata Pressure Guide Wire 185cm JTIP Verrata Pressure Guide Wire 300cm Verrata Pressure Guide Wire 185cm Verrata Pressure Guide Wire 300cm JTIP | registered |
| ZIEN MEDICAL TECHNOLOGIES, INC. | United States | XO Cath Knight Microcatheter | registered |
| Acist Medical Systems, Inc. Present in Europe in other categories | United States | ACIST RXi® System with dPR ACIST RXi® Console with dPR ACIST Navvus® Catheter | K233904 (2024) |
| Acrostak (Schweiz) AG | – | M-CATH Flexy M-CATH Microcatheter | registered |
| Bayer Healthcare, LLC Present in Europe in other categories | United States | POWER PULSE SOLENT PROXI SOLENT OMNI | registered |
| LIGHTLAB IMAGING, INC. | – | PressureWire™ | registered |
| MILLAR INC. | United States | Mikro-Cath Pressure Catheter Mikro-Tip Catheter Pulse Transducer TC-510 Pressure Control Unit | K163376 (2017) |
| OPTI MEDICAL SYSTEMS, INC. Present in Europe in other categories | United States | Comfort Sampler Bulk Comfort Sampler, Basic Kit Comfort Sampler | registered |
| Shanghai Wallaby Medical Technologies Co., Inc. | – | Wallaby 017 Micro Catheter | registered |
| VYGON Present in Europe in other categories | France | VYGON | registered |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| EKOS CORPORATION | United States | EkoSonic® | K073166 (2008) |
| Endovascular Engineering, Inc. | United States | Helo G1 Thrombectomy System Helo Thrombectomy System | registered |
| HERAEUS MEDICAL COMPONENTS LLC | United States | Poseidon | K191305 (2019) |
| KANEKA CORP. Present in Europe in other categories | Japan | SurfRider 13 Microcatheter | registered |
| Medtronic, Inc. Present in Europe in other categories | United States | Liberant™ Export Advance™ | registered |
| Surmodics, Inc. | United States | Pounce™ Venous Thrombectomy System Pounce Venous Thrombectomy System | registered |
| V.V.T. MED LTD | Israel | SclereSafe ScleroSafe | registered |
| VYAIRE MEDICAL, INC. Present in Europe in other categories | United States | AirLife™ | registered |
| BEND IT TECHNOLOGIES LTD | Israel | Bendit2.7 Steerable Microcatheter | K200582 (2020) |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| HEXACATH | France | RAYFLOW | registered |
| Inquis Medical, Inc. | United States | Aventus Thrombectomy System - Aspiration Catheter | registered |
| Jiangsu Chongheng Medical Technology Co., Ltd. | – | Hupai | registered |
| Micro Medical Solutions, Inc. | United States | MicroGuide | K152625 (2016) |
| Peak Medical Distribution Inc. | – | PEAK MEDICAL | registered |
| Reverse Medical Corporation | United States | ReverseTM | registered |
| Roche Diagnostics Corp. Present in Europe in other categories | United States | Roche MICROSAMPLER PROTECT | registered |
| SCIENTIA VASCULAR LLC | – | Plato | registered |
| SKANRAY TECHNOLOGIES LIMITED Present in Europe in other categories | India | STAR 65 | registered |
| ZURICH MEDICAL INC. | United States | Zurich Pressure Guidewire System | K190852 (2019) |
| AD Supply Group Limited | United Kingdom | – | registered |
| ATRION CORP. | United States | – | registered |
| Abbott Laboratories Present in Europe in other categories | United States | – | registered |
| Ablative Solutions, Inc. | United States | – | K231279 (2023) |
| Adroit USA Inc | United States | – | registered |
| Alembic LLC | United States | – | registered |
| Amphenol Alden Products Company | United States | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| BALT EXTRUSION | France | – | registered |
| BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD. | China | – | registered |
| BEMS Holdings, LLC | United States | – | registered |
| BMmedical | Netherlands | – | registered |
| BURAK GLOBAL IC VE DIS TIC LTD STI | Türkiye | – | registered |
| Boulder BioMed dba Boulder iQ | United States | – | registered |
| CARDIVA MEDICAL, INC. | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| CD Leycom | Netherlands | – | registered |
| CREGANNA MEDICAL IRELAND LIMITED | Ireland | – | registered |
| CUSTOMED INC Present in Europe in other categories | United States | – | K930986 (1993) |
| Callisyn Biomedical, Inc. | United States | – | K161967 (2017) |
| Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti | Türkiye | – | registered |
| Caribbean Custom Mold Inc | Dominican Republic | – | registered |
| Cerenovus, Inc. Present in Europe in other categories | United States | – | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| Culver Tool & Engineering LLC dba SpiTrex CTE | United States | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| DSV Contract Logistics | Mexico | – | registered |
| EPIC MedTec OEM Catheter & Wire LLC | United States | – | registered |
The 100 most active manufacturers are shown, out of 152.
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