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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
Electrocardiograph
Edan Instruments, Inc.
·
,
China
Class IIa
CE/MDR
GUDID
on market
Electrocardiograph
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class IIa
CE/MDR
Mac VU360
Ge Medical Systems Information Technologies, Inc.
·
,
United States
Class IIa
CE/MDR
GUDID
on market
Electrocardiogragh
Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.
·
,
China
Class IIa
CE/MDD
Electrocardiograph
Shenzhen Carewell EIectronics Co., Ltd.
·
,
China
Class IIa
CE/MDD
Ec-12R V6
LABTECH Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság.
·
,
Hungary
Class IIa
CE/MDR
Chart Box
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
GUDID
on market
Ecg
Suzhou Beneware Medical Equipment Co., Ltd.
·
,
China
Class IIa
CE/MDD
MAC 7 Resting ECG Analysis System
Ge Medical Systems Information Technologies, Inc.
·
,
United States
Class IIa
FDA 510(k)
×2
K203786
Active
Cleared 30 Apr 2021
CE/MDR
+1
authorizations
Electrocardiograph
Shenzhen Comen Medical Instruments Co., LTD.
·
,
China
Class IIa
CE/MDD
CE/MDR
CardioExpress 5012
Bionet Co., Ltd.
·
,
South Korea
Class IIa
CE/MDR
2024-MDR/QS-053/A
Active
Valid to Sep 2029
GUDID
on market
Electrocardiograph
Shenzhen Carewell EIectronics Co., Ltd.
·
,
China
Class IIa
CE/MDD
Cardio M-Pro
medical ECONET GmbH
·
,
Germany
Class IIa
CE/MDD
Ms-12 Bt
Schiller AG
·
,
Switzerland
Class IIa
CE/MDR
Electrocardiograph
Shenzhen Carewell EIectronics Co., Ltd.
·
,
China
Class IIa
CE/MDD
ECG Acquisition Systems
DM Systems (Beijing) Co., Limited
·
,
China
Class IIa
CE/MDD
Electrocardiograph
Shenzhen Carewell EIectronics Co., Ltd.
·
,
China
Class IIa
CE/MDD
CardiMax FX-8400
Fukuda Denshi Co., Ltd.
·
,
Japan
Class IIa
CE/MDR
GUDID
on market
Serial 8P Straight Cable
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
Power cable
Fukuda Denshi Co., Ltd.
·
,
Japan
Class I
CE/MDR
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