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Medical equipment and related accessories, software and consumables
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Instruments for functional explorations and therapeutic interventions
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Cardiology and cardiosurgery instruments
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Holter system instruments for cardiovascular parameters
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ECG holter recorders
ECG holter recorders
Z12050403
214 devices
Eclipse Mini Recorder, Multilingual
Spacelabs Healthcare Ltd
·
,
United Kingdom
Class IIa
CE/MDR
GUDID
on market
Holter System
Biomedical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDR
Holter System
Biomedical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDR
Nr-1207
Norav Medical GmbH
·
,
Germany
Class IIa
CE/MDR
Holter
Suzhou Beneware Medical Equipment Co., Ltd.
·
,
China
Class IIa
CE/MDD
Nr-314-P
Norav Medical GmbH
·
,
Germany
Class IIa
CE/MDR
Nr-314
Norav Medical GmbH
·
,
Germany
Class IIa
CE/MDR
PocketECG IV
Medicalgorithmics S.A.
·
,
Poland
Class IIa
CE/MDR
Holter System
Biomedical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDR
Holter System
Biomedical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDR
Holter System
Biomedical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDD
Faros14D
Bittium Biosignals, Ltd.
·
,
Finland
Class IIa
CE/MDD
Seer 12
Getemed Medizin- Und Informationstechnik AG
·
,
Germany
Class IIa
CE/MDD
GUDID
on market
Holter
Suzhou Beneware Medical Equipment Co., Ltd.
·
,
China
Class IIa
CE/MDD
Holter ECG Workstation
BORSAM Biomedical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDD
CardioWaver
SynexCare Sp. z o.o.
·
,
Poland
Class IIa
CE/MDR
TNP/MDR/0041/5915/2025
Active
Valid to Sep 2028
Holter
Shenzhen ECGMAC Medical Electronics Co., Ltd.
·
,
China
Class IIa
CE/MDD
Holter System
Biomedical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDD
Holter System
Edan Instruments, Inc.
·
,
China
Class IIa
FDA 510(k)
K151787
Active
Cleared 27 Jan 2016
CE/MDR
+1
authorizations
H12B-plus
Shenzhen ECGMAC Medical Electronics Co., Ltd.
·
,
China
Class IIa
CE/MDD
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