Instruments for functional explorations and therapeutic interventionsInstruments to support and monitor vital signs
Various instruments to support and monitor vital signs
EMDN code Z120390
Manufacturers registered in Europe (EUDAMED) 7
- 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) 43
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 |
|---|---|---|---|
| MEDTRONIC PS MEDICAL, INC. | United States | Becker® Exacta™ Duet® Becker | K983799 (1999) |
| Natus Medical Incorporated Present in Europe in other categories | United States | Natus CAMINO® | registered |
| Braincare Desenvolvimento E Inovacao Tecnologica S.A. | Brazil | Braincare | K240821 (2024) |
| M DIALYSIS INC. Present in Europe in other categories | Sweden | 70 Microdialysis Bolt Catheter 130/10, 4/pkg 106 Microdialysis Pump Rinsing Fluid 0.5 L 8/pkg 106 Syringe Microvials in rack, Sterile 12x4 Microvial rack 12/pkg | registered |
| Branchpoint & Aura Development LLC | United States | AURA | registered |
| Hemedex Incorporated | United States | QFlow 500 Titanium Bolt-Dual Lumen QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit QFlow 500 Titanium Bolt-Single Lumen QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer QFlow 500 Male-Female Luer Coupler QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit | K141869 (2014) |
| ClearPoint Neuro, Inc. Present in Europe in other categories | United States | Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor IRRAflow Cranial Access Bolt IRRAflow® IRRAflow® Cassette and Tube Set IRRAflow® 2.0 Catheter IRRAflow Tube Set | registered |
| Samsung Electronics Co., Ltd. Present in Europe in other categories | South Korea | Samsung ECG App v 1.3 (ECG) Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | registered |
| ICU MEDICAL, INC. Present in Europe in other categories | United States | Medex | registered |
| XLTEK | Canada | Natus | registered |
| APRAMED INDUSTRIA E COMERCIO DE APARELHOS MEDICOS LTDA | Brazil | – | registered |
| Amphenol Alden Products Company | United States | – | registered |
| Blueprint Manufacturing Corporation | United States | – | registered |
| Boulder BioMed dba Boulder iQ | United States | – | registered |
| BrainSpace | United States | – | registered |
| Branchpoint Technologies, Inc. | United States | – | K172209 (2018) |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| Codman & Shurtleff, Inc. | United States | – | K173192 (2017) |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| DSV Contract Logistics | Mexico | – | registered |
| Dylan Lucas International Inc | Canada | – | registered |
| ELLA-CS, s.r.o. | Czechia | – | registered |
| Gebr. Brasseler GmbH & Co. KG | Germany | – | registered |
| Global Interconnect, Inc. | United States | – | registered |
| Hipp Medical AG Present in Europe in other categories | Germany | – | registered |
| Innerspace Neuro Solutions, Inc. | United States | – | K161010 (2016) |
| Liberty Engineering Inc. | United States | – | registered |
| MILLAR INC. | United States | – | registered |
| Medeologix LLC | United States | – | registered |
| Medos International Sàrl Present in Europe in other categories | Switzerland | – | K152670 (2016) |
| Medtronic, Inc. Present in Europe in other categories | United States | – | K201118 (2020) |
| Nissha Medical Technologies Present in Europe in other categories | United States | – | registered |
| PLEXUS CORP. | United States | – | registered |
| Pan-International Precision Electronic Co., Ltd. | China | – | registered |
| QUALITEL CORPORATION | United States | – | registered |
| RECO MEDIZINTECHNIK Wolfgang Rentsch eK | Germany | – | registered |
| RUDOLF STORZ GMBH | Germany | – | registered |
| Resolution Medical, LLC | United States | – | registered |
| Rose Medical | United States | – | registered |
| SHANGHAI MEDICAL INSTRUMENTS (GROUP) LTD. CORP. | China | – | registered |
| SHANGHAI WILPOWER INDUSTRIAL CO., LTD | China | – | registered |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Present in Europe in other categories | China | – | registered |
| TECHNICAL SERVICES FOR ELECTRONICS, INC. | United States | – | registered |
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