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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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Obstetrics and gynaecology instruments
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Prenatal diagnostic instruments
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Prenatal diagnostic instruments - medical device software
Prenatal diagnostic instruments - medical device software
Z12080192
14 devices
Devices
Sonio Detect
Sonio
·
,
FR
Class IIa
FDA 510(k)
K230365
Active
Cleared 25 Jul 2023
FDA 510(k)
K240406
Active
Cleared 26 Apr 2024
+2
authorizations
IntelliSpace Perinatal K Large Arch.
Philips Medizin Systeme Böblingen GmbH
·
,
DE
Class IIa
CE/MDD
GUDID
on market
IntelliSpace Perinatal K Small Arch.
Philips Medizin Systeme Böblingen GmbH
·
,
DE
Class IIa
CE/MDD
astraia – software for women's health - obstetric and gynaecological database a…
NEXUS / ASTRAIA GmbH
·
,
DE
Class IIa
CE/MDR
FraiyaScan
Fraiya Ltd
·
,
GB
Class IIa
CE/MDR
SCAR-4.2.1.1
Active
Valid to Jul 2030
astraia – software for women's health
NEXUS / ASTRAIA GmbH
·
,
DE
Class IIa
CE/MDR
Sonio Suspect
Sonio
·
,
FR
Class IIa
FDA 510(k)
K243614
Active
Cleared 21 Feb 2025
CE/MDR
+1
authorizations
Trium CTG Online
Trium Analysis Online GmbH
·
,
DE
Class IIb
CE/MDR
Sonio Detect
Sonio
·
,
FR
Class IIa
CE/MDR
GUDID
on market
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