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CardioComm Solutions, Inc

US

Last updated May 24, 2026

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 251043907

Catalogue (19)

Device	Model / Reference	Registries	Class	Status
GEMS Win Arrhythmia	GW-ARR	FDA UDI	Class II	Active
GEMS Win TTM & ICD	GW-TTMICD	FDA UDI	Class II	Active
HeartCheck CardiBeat	HC-WC-01	FDA UDI	Class II	Active
GEMS Win AutoAttendant	GW-AA	FDA UDI	Class II	Active
GEMS Win HL7	GW-HL7	FDA UDI	Class II	Active
HeartCheck Palm	HC-PM10	FDA UDI	Class II	Active
HeartCheck BT PEN Handheld ECG	HCEKGBTPEN30	FDA UDI	Class II	Active
GEMS Win TTM	GW-TTM	FDA UDI	Class II	Active
GEMS Mobile ECG	GM	FDA UDI	Class II	Active
GEMS Win Air	GW-AIR	FDA UDI	Class II	Active
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile	K181310	FDA 510(k)	Class II	Active
Guava Ii	K122632	FDA 510(k)	Class II	Active
Globalcardio	K111320	FDA 510(k)	Class II	Active
Global Ecg Management System (gems)	K022297	FDA 510(k)	Class II	Active
Modification To Globalcardio	K033037	FDA 510(k)	Class II	Active
Heartcheck Ecg Pen With Gems Home	K121009	FDA 510(k)	Class II	Active
Globalcardio	K013354	FDA 510(k)	Class II	Active
Heartcheck Pen Handheld Ecg With Gems Home	K111159	FDA 510(k)	Class II	Active
Global Ecg Management System (gems)	K020366	FDA 510(k)	Class II	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Cardiocomm Solutions, Inc. North York Ontario · CA FEI 3003708031