Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instrumentsHolter system instruments for cardiovascular parameters
Holter system instruments for cardiovascular parameters - software accessories
EMDN code Z12050482
Manufacturers registered in Europe (EUDAMED) 6
- 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 |
|---|---|---|---|---|
| Cardioline FDA | Italy |
|
IIa 93/42 | Website compliance@cardioline.com EUDAMED record Report an error |
| Meditech FDA | Hungary |
|
IIa 93/42 | Website EUDAMED record Report an error |
| Welch Allyn FDA EU representative : Welch Allyn Limited (Ireland) | United States |
|
IIa 93/42 | Website EUDAMED record Report an error |
| Bittium FDA | Finland | IIa MDR | Website EUDAMED record Report an error | |
| Philips FDA EU representative : Philips Medizin Systeme Böblingen GmbH (Germany) | United States | IIa 93/42 | eudamed@philips.com EUDAMED record Report an error | |
| Spacelabs Healthcare FDA EU representative : MediMark Europe Sarl. (France) | United Kingdom (ex Northern Ireland) | IIa MDR | 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) 26
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 |
|---|---|---|---|
| Mortara Instrument, Inc. | United States | HScribe Modality Manager Scribe Vision | K004017 (2001) |
| Global Instrumentation, LLC | United States | Patient Cable Matrix Holter System GI Holter System WA Holter System Pouch Battery Cover | K051730 (2005) |
| Norav Medical , Ltd. Present in Europe in other categories | Israel | Norav 1200 Series PC-ECG Holter analysis software + Data base. Includes download device according to reco Holter down load and review software. Includes download device according to reco Ambulatory ECG Analysis Software Holter Analysis software. Includes download device according to recorder type. | K111487 (2011) |
| Midmark Corp. Present in Europe in other categories | United States | Midmark IQholter® Digital Holter Recorder Midmark IQholter EX Digital Holter Prep Kit - Midmark IQholter, 5-lead Midmark IQholter® Digital Holter Recorder Kit Midmark IQholter Digital Holter MIDMARK IQHOLTER® PLUG-IN SOFTWARE | registered |
| BRAEMAR MANUFACTURING, LLC Present in Europe in other categories | United States | ER9W 3GSM Brookings ER9W CDMA UNM ER9W CDMA wEvent ER9W wEvent 3GSM ER9W Cardiomedix ER9W CDMA First Call Med | registered |
| LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság | – | Cardiospy ECG Holter System | registered |
| Neurotronics, LLC Present in Europe in other categories | United States | Polysmith Version 12.2 Polysmith Version 12.0 Polysmith Version 11.0 Polysmith | registered |
| ATsens Co., Ltd. Present in Europe in other categories | South Korea | AT-Patch AT-Report | registered |
| Contec Medical Systems Co., Ltd. Present in Europe in other categories | China | CONTEC | registered |
| Medicomp, Inc. | United States | TelePatch Cardiac Monitor | K043454 (2005) |
| VIVAQUANT, INC. | United States | Rhythm Express | K200833 (2020) |
| FOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITED | India | Frontier X Plus | registered |
| MEDIBLU MEDICAL LLC | United States | Mediblu | registered |
| Philips Medical Systems Hsg | – | Holter Software | registered |
| Tiger Supplies Inc | – | Viva Diagnostic | registered |
| Baxter Healthcare Corp Present in Europe in other categories | United States | – | registered |
| Cardiocalm Srl | Italy | – | K193177 (2020) |
| ClearPath Medical, LLC | United States | – | registered |
| Emsere, Inc | Netherlands | – | registered |
| Fourth Frontier Technologies Pvt, Ltd. | India | – | K240794 (2024) |
| Giken Sakata (S) Ltd | Singapore | – | registered |
| Kaynes Technology India Limited | India | – | registered |
| Labtech Kereskedelmi es Mernoki Szolgaltato Kft | Hungary | – | registered |
| Porticos Asia Limited | Hong Kong SAR China | – | registered |
| Quipment | France | – | registered |
| Zbeats, Inc. | United States | – | K261580 (2026) |
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