Instruments for functional explorations and therapeutic interventionsCardiology and cardiosurgery instruments

Holter system instruments for cardiovascular parameters

EMDN code Z120504

52 manufacturers, 173 models including 169 on the market, 20 countries

On the market in Models on the market only Include accessories and consumables Manufacturer country

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
Livetec	Germany	auxil ECG93/42 Cardioline ECG4 refs dpv-ritmo III93/42 ECG Time S93/42 ECG Time S Accu93/42 12 others ECG Time S Accu Zimmer93/42 ECG Time S Zimmer93/42 kECG-393/42 kECG-3 ACE93/42 kECG-3 ALTO93/42 kECG-3 EOS93/42 kECG-3 HARTIS93/42 kECG-3 Kardiobeat.ai93/42 kECG-3 VINE93/42 liveECG-V293/42 liveECG-V2 AXIS93/42 net_ECG SDX93/42	IIa MDR, 93/42	Website info@livetec.de EUDAMED record Report an error
Beneware EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Holter CP-02293/42 Holter CP-02593/42 Holter CT-0893/42 Holter CT-08193/42 Holter CT-081S93/42 8 others Holter CT-08293/42 Holter CT-082S93/42 Holter CT-08393/42 Holter CT-083S93/42 Holter CT-08593/42 Holter CT-08693/42 Holter CT-086S93/42 Holter CT-08S93/42	IIa 93/42	Website EUDAMED record Report an error
Labtech	Hungary	EC-12H Holter Recorder93/42 EC-12H Recorder EC type Holter systems3 refs EC-12H System93/42 EC-2H Holter Recorder93/42 EC-2H System93/42 5 others EC-3H Holter Recorder93/42 EC-3H System93/42 EC-3H/ABP Recorder93/42 EC-3H/ABP System93/42 EC-ABP2 refs93/42	IIa MDR, 93/42	Website info@labtech.hu EUDAMED record Report an error
BORSAM Biomedical Instruments EU representative : Kingsmead Service B.V. (Netherlands)	China	ECG Event Recorder WeCardio TTM93/42 ECG Event Recorder WeCardio UN93/42 ECG Event Recorder WeCardio WF93/42 Holter ECG Workstation BS6930-1293/42 Holter ECG Workstation BS6930-393/42 4 others Holter ECG Workstation BS6940-1293/42 Holter ECG Workstation BS6940-393/42 Holter ECG Workstation Holter Patch93/42 Holter ECG Workstation iTengo93/42	IIa 93/42	Website EUDAMED record Report an error
Appsens	Norway	ECG247 Electrode Patch93/42 ECG247 Hjerteovervåker 353 0103 refs ECG247 Sensore Cardiaco ECG Smart Sensor model 353 01093/42 ECG247 Smart Heart Sensor ECG247 model 353 01093/42 ECG247 Smart Sensor and Electrode ECG247 Smart Sensor model 353 01093/42 3 others ECG247 Smart Sensor APP ECG247APP93/42 ECG247 Smart Sensor ECG247 model 353 0102 refs93/42 ECG247 Software Solution ECG247 Back-end Cloud Service93/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Biomedical Instruments EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	BI500093/42 BI5000B93/42 BI660093/42 BI680093/42 BI910093/42 3 others BI9800TL+93/42 BI990093/42 Holter System BI9900, BI9100, BI9800, BI9000, BI6812, BI6803, BI6612, BI6603, EP820, EP820-12, EP830, EP830-12, CSC 6612, TRAK-48,BIP-03A BIP-03B, BIP-03C, BIP-01A, BIP-01B, BIP-01C3 refs	IIa MDR, 93/42	Website EUDAMED record Report an error
Spacelabs Healthcare FDA EU representative : MediMark Europe Sarl. (France)	United Kingdom (ex Northern Ireland)	90227, ONTRAK (TUMMEL)2 refs ABP ULTRALITE MONITOR, GERMAN ECLIPSE MINI RECORDER, MULTILINGUAL2 refs ECLIPSE PRO RECORDER,MULTILINGUAL LIFECARD CF DIGITAL HOLTER MON 3 others LIFESCREEN PRO ANALYSER, V1.X PATHFINDER SL ANALYSER2 refs 4 ELECTRODE EVO RECORDER PACKED3 refs (no longer marketed)	I, IIa MDR	Website EUDAMED record Report an error
Cardios EU representative : Obelis s.a. (Belgium)	Brazil	CardioLight+ Holter Recorder93/42 CardioSmart CS550 EN93/42 CardioSmart CS550 ES93/42 CardioSmart CS550 FR93/42 Enregistreur Holter CardioLight+ CardioLight+ FR93/42 1 other Grabadora Holter CardioLight+ CardioLight+ ES93/42	IIa 93/42	Website sales@cardios.com.br EUDAMED record Report an error
Bittium FDA	Finland	14D93/42 18093/42 180L93/42 36093/42 Faros Pro2 refs	IIa MDR, 93/42	Website EUDAMED record Report an error
Ecgmac EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	H12B93/42 H12B-plus93/42 H3B93/42 H3B-plus93/42 H3C93/42	IIa 93/42	EUDAMED record Report an error
Getemed FDA	Germany	CardioMem CM 4000B93/42 HeartX SEER 1000 48 hour93/42 SEER 1000 7 Day93/42 SEER 1293/42	IIa MDR, 93/42	Website EUDAMED record Report an error
Schiller FDA EU representative : SCHILLER Medizintechnik GmbH (Germany)	Switzerland	BR-102 plus 3.90047093/42 BR-102 plus PWA93/42 medilog DARWIN2 AAM medilogDARWIN22 refs MedilogAR medilogFD	IIa MDR, 93/42	Website info@schiller.ch EUDAMED record Report an error
Aerotel FDA EU representative : AF Pharma Service Europe SL (Spain)	Israel	12i93/42 12L93/42 P12/8 Mobile93/42 P12/8i93/42	IIa 93/42	EUDAMED record Report an error
Cardioline FDA	Italy	click holter+93/42 Clickholter93/42 Walk200b93/42 Walk400h93/42	IIa 93/42	Website compliance@cardioline.com EUDAMED record Report an error
CustoMED FDA	Germany	custo flash 5003 refs custo guard 12 refs custo screen 3003 refs Viollier guard holter guardholter3 refs	IIa MDR	info@customed.de EUDAMED record Report an error
DM Systems (Beijing) EU representative : ADVANCED MEDICAL SYSTEMS SL (Spain)	China	Holter Recorder DMS300-2W93/42 Holter Recorder DMS300-3A93/42 Holter Recorder DMS300-4A93/42 Holter Recorder DMS300-4AL93/42	IIa 93/42	EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ambulatory Blood Pressure Monitor3 refs Holter ECG and ABP system3 refs Holter System SE-20033 refs Holter System SE-30122 refs	IIa MDR	EUDAMED record Report an error
Microport FDA	Italy	HookUp Smart RC013 ECG cables3 refs SMART ECG SpiderFlash single use bag3 refs	I, IIa MDR	contact@crm.microport.com EUDAMED record Report an error
Vasomedical FDA EU representative : phoenix Medtech GmbH (Germany)	United States	Ambulatory Electrocardiograph Model 1303 Model 1306 Model 1805 Model 2303	IIa MDR	EUDAMED record Report an error
Research Production Monitor EU representative : CMC Medical Devices & Drugs SL (Spain)	Russia	ECG Holter recorder EHR-0193/42 ECG portable recorder EPR-0193/42 ECG wireless recorder EWR-0193/42	IIa 93/42	Website EUDAMED record Report an error
Viatomtech FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Checkme ER1-LW，ER1-LB3 refs Checkme M5，M12，Lepod，Lepod Pro，LMT-5，LMT-123 refs LEPU MEDICAL XAB-M3AG、 XAB-M12AL、 iHolter-3、 iHolter-12、 LeHolter-3、 LeHolter-123 refs	IIa MDR	EUDAMED record Report an error
Biocare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Ambulatory Blood Pressure Recorders and Associated Software iH-B Ambulatory Electrocardiographs iH-12PLUS，iH-3PLUS2 refs	IIa MDR	regulation@biocare.com.cn EUDAMED record Report an error
IEM FDA	Germany	Amedtec ECGpro Holter-RR USB-C93/42 Scanlight by IEM USB-C93/42	IIa 93/42	regulatory@iem.de EUDAMED record Report an error
Meditech FDA	Hungary	ABPM-0693/42 CardiUP!93/42	IIa 93/42	Website EUDAMED record Report an error
Novacor	France	Brassard Diasys 3 Large Accessories Cuff systems3 refs Câble ECG 5 brins Standard Gris (CHB)3 refs	I MDR	Website EUDAMED record Report an error
Shenzhen Benevolence Medical Sci&Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	benecare M93/42 benecare U93/42	IIa 93/42	EUDAMED record Report an error
Shenzhen Carewell EIectronics EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands)	China	TH1293/42 TH393/42	IIa 93/42	EUDAMED record Report an error
THOTH (Suzhou) Medical Technology EU representative : Everbiz GmbH (Germany)	China	Wearable DECG Recorder TER011、TER012、EP-33 refs Wearable ECG Sensor LES-1、LES-2、LES-3、LES-X3 refs	I, IIa MDR	EUDAMED record Report an error
Welch Allyn FDA EU representative : Welch Allyn Limited (Ireland)	United States	Welch Allyn H12+ 90114126 refs93/42 Welch Allyn H3+ 90114235 refs93/42	IIa 93/42	Website EUDAMED record Report an error
Braemar Manufacturing FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands)	United States	ePatch 2.5 ECG Recorder93/42 ePatch 2.0 Sensor93/42 (no longer marketed)	IIa 93/42	eudamed@philips.com EUDAMED record Report an error
AthenaDiaX	Germany	ARES 01-10093/42	IIa 93/42	Website info@athenadiax.com EUDAMED record Report an error
ATsens FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	South Korea	AT-Patch ATP-C13093/42	IIa 93/42	Website sales@atsens.com EUDAMED record Report an error
BTL Industries FDA EU representative : BTL ITALIA S.r.l. (Italy)	United Kingdom (ex Northern Ireland)	BTL ABPM NG Pro	IIa MDR	EUDAMED record Report an error
Contecmed FDA EU representative : Prolinx GmbH (Germany)	China	Dynamic ECG Systems TLC5000, TLC60002 refs	IIa MDR	Website pms.qms@contecmed.com EUDAMED record Report an error
Cortrium	Denmark	C3+ Holter Monitor2 refs	IIa MDR, 93/42	Website eudamed@cortrium.com EUDAMED record Report an error
dms-service FDA EU representative : QNET B.V. (Netherlands)	United States	myPatch®sl 3000sl	IIa MDR	Website EUDAMED record Report an error
Larganmed FDA EU representative : MDSS GmbH (Germany)	Taiwan	AT-202B93/42	IIa 93/42	Website EUDAMED record Report an error
Medbeat	Sweden	VIVO-01	IIa MDR	Website contact@medbeat.se EUDAMED record Report an error
Medicalgorithmics FDA	Poland	PocketECG IV P4TR-CE-ADS3 refs	IIa MDR	Website regulatory@medicalgorithmics.com EUDAMED record Report an error
Norav FDA EU representative : Norav Medical GmbH (Germany)	Germany, Israel	NR-1207 NR Series Ambulatory-ECG6 refs	IIa MDR	Website info@norav.com EUDAMED record Report an error
PhysioSign Hong Kong Medical EU representative : Everbiz GmbH (Germany)	China	Multichannel Electrocardiograph PHS-U10	IIa MDR	EUDAMED record Report an error
Rooti Labs FDA EU representative : Obelis s.a. (Belgium)	Taiwan	Rooti Rx3 refs	IIa MDR	eudamed@rootilabs.com EUDAMED record Report an error
Shenzhen Aeon Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	ECG RECORDER HeartPATCH-BT	IIa MDR	Website EUDAMED record Report an error
Shenzhen Med-link Electronics Tech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	ECG Recorder ECG0101010293/42	IIa 93/42	Website sales@med-linket.com EUDAMED record Report an error
Suzhou Melodicare Medical Technology FDA EU representative : Share Info Consultant Service LLC Repräsentanzbüro (Germany)	China	Mintti MCT-H193/42	IIa 93/42	EUDAMED record Report an error
SynexCare	Poland	CardioWaver	IIa MDR	EUDAMED record Report an error
Systole	Netherlands	Multichannel ECG Recorder H493/42	IIa 93/42	quality@systole.nl EUDAMED record Report an error
TeMeCo	Netherlands	SenseLink3 refs	IIa MDR	Website info@temeco.nl EUDAMED record Report an error
TZ Medical FDA EU representative : CEpartner4U (Netherlands)	United States	Clarus Holter H3R-0039	IIa MDR	Website info@tzmedical.com EUDAMED record Report an error
Zive	Lithuania	ZIVE ECG193/42	IIa 93/42	Website hello@zive.io EUDAMED record Report an error
Diagnostic Devices Development No model still on the market	Finland	CloudHolter93/42 (no longer marketed)	IIa 93/42	Website info@ddd-medical.com EUDAMED record Report an error
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands) No model still on the market	United States	DigiTrak XT Holter Recorder93/42 (no longer marketed)	IIa 93/42	eudamed@philips.com EUDAMED record Report an error

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