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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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Electrocardiographs
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General purpose electrocardiographs
General purpose electrocardiographs
Z12050301
307 devices
CardiMax FX-8200
Fukuda Denshi Co., Ltd.
·
,
Japan
Class IIa
CE/MDR
ECG Interpretation Software
Fukuda Denshi Co., Ltd.
·
,
Japan
Class IIa
CE/MDR
GUDID
on market
Trolley
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
Standard 10-lead Patient Cable IEC
Philips Medical Systems
·
,
United States
Class I
CE/MDR
Cardiovit At-1 G2
Schiller AG
·
,
Switzerland
Class IIa
CE/MDD
MAC 5 A5 Resting ECG Analysis System
Ge Medical Systems Information Technologies, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Easy ECG Monitor
Shenzhen Creative Industry Co., Ltd.
·
,
China
Class IIa
CE/MDR
CardioCare@Home Multi Lead Linear
Byteflies NV
·
,
Belgium
Class I
CE/MDR
Electrocardiograph
Shenzhen Carewell EIectronics Co., Ltd.
·
,
China
Class IIa
CE/MDD
Patient Cables CMS-05 series
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
ECG Recorder
Shenzhen Viatom Technology Co., Ltd.
·
,
China
Class IIa
CE/MDR
Electrocardiograph
Bionet Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
GUDID
on market
Electrocardiograph
Edan Instruments, Inc.
·
,
China
Class IIa
CE/MDR
Electrocardiograph
Shenzhen Comen Medical Instruments Co., Ltd.
·
,
China
Class IIa
CE/MDR
Electrocardiograph
Shenzhen Carewell EIectronics Co., Ltd.
·
,
China
Class IIa
FDA 510(k)
K113485
Active
Cleared 25 Apr 2012
CE/MDD
CardiMax FX-8100
Fukuda Denshi Co., Ltd.
·
,
Japan
Class IIa
CE/MDR
Mac 7 Sw Upg Kit
Ge Medical Systems Information Technologies, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Electrocardiograph
Shenzhen Comen Medical Instruments Co., LTD.
·
,
China
Class IIa
CE/MDR
Ecg-3350
Shanghai Kohden Medical Electronic Instrument Corp.
·
,
China
Class IIa
CE/MDR
Electrocardiograph
Shenzhen Comen Medical Instruments Co., LTD.
·
,
China
Class IIa
CE/MDR
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