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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 telemetry instruments (ECG, nipb, etco2, spo2, respiration,...)
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Complete vital signs telemetry systems
Complete vital signs telemetry systems
Z1203020601
7 devices
Devices
EmbracePlus
Empatica S.r.L.
·
,
IT
Class IIa
FDA 510(k)
K242737
Active
Cleared 6 Jun 2025
CE/MDR
Empatica Care - Android
Empatica S.r.L.
·
,
IT
Class IIa
CE/MDR
GUDID
on market
Empatica Care
Empatica S.r.L.
·
,
IT
Class IIa
CE/MDR
GUDID
on market
EmbracePlus
Empatica S.r.L.
·
,
IT
Class IIa
CE/MDR
GUDID
on market
EmbracePlus with Elastic Strap
Empatica S.r.L.
·
,
IT
Class IIa
CE/MDR
Coala Heart Monitor
Coala Solutions AB
·
,
SE
Class IIa
CE/MDR
EmbracePlus Stretchable Band - Black
Empatica S.r.L.
·
,
IT
Class IIa
CE/MDR
GUDID
on market
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