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Various medical devices
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Measurement devices
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Body temperature measurement devices
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Body temperature measuring devices - other
Body temperature measuring devices - other
V030199
34 devices
Devices
OvuSense Realtime Fertility Monitor
viO HealthTech Limited
·
,
GB
Class IIa
CE/MDD
F5417/Ter
FIAB S.p.A.
·
,
IT
Class IIb
CE/MDR
SteadySense Patch
SteadySense GmbH
·
,
AT
Class I
CE/MDR
St-Monitor
FIAB S.p.A.
·
,
IT
Class IIb
CE/MDR
GUDID
on market
BreastCheck
Davion Healthcare PLC
·
,
IE
Class I
CE/MDR
St-Ptcbl
FIAB S.p.A.
·
,
IT
Class IIb
CE/MDR
Body Temperature Software
Fitbit LLC
·
,
US
Class IIa
FDA De Novo
DEN230050
Active
Cleared 15 Dec 2023
CE/MDR
+1
authorizations
OvuSense Realtime Fertility Monitor
viO HealthTech Limited
·
,
GB
Class IIa
CE/MDD
St-Ptcbl
FIAB S.p.A.
·
,
IT
Class IIb
CE/MDR
FootFlow
Davion Healthcare PLC
·
,
IE
Class I
CE/MDR
SteadyTemp
SteadySense GmbH
·
,
AT
Class I
FDA 510(k)
K233280
Active
Cleared 21 Jun 2024
CE/MDD
SteadyTemp
SteadySense GmbH
·
,
AT
Class I
CE/MDR
CE/MDD
OvuSense Realtime Fertility Monitor
viO HealthTech Limited
·
,
GB
Class IIa
CE/MDD
OvuSense Realtime Fertility Monitor
viO HealthTech Limited
·
,
GB
Class IIa
CE/MDD
SteadySense Patch Sensitive
SteadySense GmbH
·
,
AT
Class I
CE/MDR
OvuSense Realtime Fertility Monitor
viO HealthTech Limited
·
,
GB
Class IIa
CE/MDD
St-Ptcbl
FIAB S.p.A.
·
,
IT
Class IIb
CE/MDR
GUDID
on market
OvuSense Realtime Fertility Monitor
viO HealthTech Limited
·
,
GB
Class IIa
CE/MDD
30114
FIAB S.p.A.
·
,
IT
Class IIb
CE/MDR
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