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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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Instruments to support and monitor vital signs
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Vital signs monitoring instruments
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Central information computing systems
Central information computing systems
Z12030201
116 devices
Devices
Patient monitor
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class IIb
CE/MDR
Upper Arm Blood Pressure Monitor
Shenzhen Zhengkang Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
GUDID
on market
Dornier UIMS
Dornier Medtech GmbH
·
,
DE
Class IIb
CE/MDR
Portrait CVAXB
Ge Medical Systems Information Technologies, Inc.
·
,
US
Class IIb
CE/MDR
GUDID
on market
DYNASCOPE 8000 Series DS-8900 System
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIb
CE/MDR
GUDID
on market
Patient monitor
Shenzhen Mindray Bio-Medical Electronics Co., LTD
·
,
CN
Class IIb
CE/MDR
Quantum Informatics - Vision / Live Vue
Spectrum Medical Ltd
·
,
GB
Class I
CE/MDR
Portrait CVAXB
Ge Medical Systems Information Technologies, Inc.
·
,
US
Class IIb
CE/MDR
Oximeter
Shenzhen Zhengkang Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
Connection Cable
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
GUDID
on market
DYNASCOPE 7000 series Central Monitor DS-7700 system
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIb
CE/MDR
GUDID
on market
DYNASCOPE 7000 series Central Monitor DS-7700 system
Fukuda Denshi Co., Ltd.
·
,
JP
Class IIb
CE/MDR
GUDID
on market
Central Monitoring System
Open recall
Edan Instruments, Inc.
·
,
CN
Class IIb
FDA 510(k)
K232694
Active
Cleared 5 Feb 2024
FDA 510(k)
K143695
Active
Cleared 30 Mar 2015
+5
authorizations
Oximeter
Shenzhen Zhengkang Technology Co., Ltd.
·
,
CN
Class IIa
CE/MDR
BMI - berekening
Ksyos Health Management Research B.V.
·
,
NL
Class I
CE/MDR
Whip Antenna
Fukuda Denshi Co., Ltd.
·
,
JP
Class I
CE/MDR
Portrait Core Services CSSXB
Ge Medical Systems Information Technologies, Inc.
·
,
US
Class IIb
CE/MDR
ObesiQ - vragenlijst
Ksyos Health Management Research B.V.
·
,
NL
Class I
CE/MDR
Dornier UIMS
Dornier Medtech GmbH
·
,
DE
Class IIb
CE/MDR
Central Monitoring System
Guangdong Biolight Meditech Co., Ltd
·
,
CN
Class IIb
FDA 510(k)
K153580
Active
Cleared 7 Sep 2016
FDA 510(k)
K170514
Active
Cleared 24 May 2017
+1
authorizations
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