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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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Vital signs monitoring instruments - medical device software
Vital signs monitoring instruments - medical device software
Z12030292
46 devices
Devices
AsTer Total Care
Gpi S.P.A.
·
,
IT
Class IIa
CE/MDR
IT321284
Active
Valid to Feb 2028
BreathCare Oxy WEB
Nanjing Yuyue Software Technology Co., Ltd.
·
,
CN
Class I
CE/MDR
ABPMpro Software
SOMNOmedics AG
·
,
DE
Class IIa
CE/MDR
NARCOguide® T Software
SOMNOmedics AG
·
,
DE
Class I
CE/MDR
Padsy Rr 1.14
Medset Medizintechnik GmbH
·
,
DE
Class IIa
CE/MDR
44911221064
Active
Valid to Jul 2029
Data Management Software
Edan Instruments, Inc.
·
,
CN
Class I
CE/MDR
GUDID
on market
Piattaforma Aizoi
Aizoi s.r.l.
·
,
IT
Class IIa
CE/MDD
Braintrend Software
Mt Monitortechnik GmbH & Co. KG
·
,
DE
Class IIb
CE/MDR
Preventicus Coach / Preventicus 360°
Preventicus GmbH
·
,
DE
Class I
CE/MDR
OptiBP
Effectum Medical AG
·
,
CH
Class IIa
CE/MDR
1000318721
Active
Valid to Jan 2028
DOMINO Software
SOMNOmedics AG
·
,
DE
Class IIa
CE/MDR
Nexus / Pdms
NEXUS / CMC GmbH
·
,
DE
Class IIa
CE/MDR
BioScan 1.0
MEDDI hub a.s.
·
,
CZ
Class I
CE/MDR
Themis
Medical Support Offshore Ltd
·
,
GB
Class I
CE/MDR
Narcotrend Software
Mt Monitortechnik GmbH & Co. KG
·
,
DE
Class IIb
CE/MDR
Phebo
Gpi S.P.A.
·
,
IT
Class IIa
CE/MDR
IT321284
Active
Valid to Feb 2028
Central Monitoring System Software
Shenzhen Comen Medical Instruments Co., LTD.
·
,
CN
Class IIb
CE/MDR
CN23/00001577
Active
Valid to Mar 2028
Ceiba Tele Icu Sağlik Hi̇zmetleri̇ Ve Ti̇caret A.Ş.
Ceiba Tele Icu Sağlik Hi̇z.ve Ti̇c.a.ş
·
,
TR
Class I
CE/MDR
IntelliVue GuardianSoftware
Philips Medizin Systeme Böblingen GmbH
·
,
DE
Class IIb
FDA 510(k)
K161767
Active
Cleared 27 Jan 2017
FDA 510(k)
K151736
Active
Cleared 21 Oct 2015
+3
authorizations
DOMINO light Software
SOMNOmedics AG
·
,
DE
Class IIa
CE/MDR
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