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CardioSen'C
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref E-430-0 to E-434-0, E-436-0, E-445-0510(k) K080047
Identity
- Trade Name
- CardioSen'C FDA UDI
- Generic Name
- Electrocardiograph, home-use FDA UDI
- Device Name
- CardioSen'C EUDAMEDThe CardioSen’C is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere and anytime, to a physician's office, hospital or monitoring center. The ECG measurement can be transmitted in real time via two distinct channels. The CardioSen’C produces an ECG-modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The data can also be transmitted digitally through a cellular telephone network by use of the device’sintegrated cellular modem. Either one of these two transmissions permits the complete and reliable transfer of a 12-lead ECG immediately to a certified medical body capable of interpreting the results. FDA UDI
- Model / Reference
- E-430-0 to E-434-0, E-436-0, E-445-0 EUDAMED4.2 FDA UDI
- Description
- The CardioSen’C is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere and anytime, to a physician's office, hospital or monitoring center. The ECG measurement can be transmitted in real time via two distinct channels. The CardioSen’C produces an ECG-modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The data can also be transmitted digitally through a cellular telephone network by use of the device’sintegrated cellular modem. Either one of these two transmissions permits the complete and reliable transfer of a 12-lead ECG immediately to a certified medical body capable of interpreting the results. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290008960250 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290008960250 EUDAMED
- 510(k) Number
- K080047 FDA UDI
- FDA Product Code
- DXH FDA UDI
- EMDN Code
- Z12050803 ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS EUDAMED
- GMDN Term
- Electrocardiograph, home-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2920 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 300 Gram FDA UDIHeight — 4 Centimeter FDA UDIWidth — 7 Centimeter FDA UDILength — 13 Centimeter FDA UDI
CardioSen'C by Shl Telemedicine International Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K080047 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07290008960250 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SHL Telemedicine International Ltd.
- EUDAMED SRN
- IL-MF-000021473
- FDA Applicant
- Shl Telemedicine International , Ltd.
- Authorised Representative
- SHL Telemedizin GmbH DE-AR-000016273
Sources (5)
- EUDAMED 4bb12e6b-9569-4189-a9aa-b4221bf1ff89 85 fields · synced Jun 19, 2026
- FDA UDI 24c662a5-bf41-444b-b112-b266225fcca5 37 fields · synced May 30, 2026
- EUDAMED 4bb12e6b-9569-4189-a9aa-b4221bf1ff89-1 61 fields · synced Jun 10, 2026
- EUDAMED 4bb12e6b-9569-4189-a9aa-b4221bf1ff89-2 61 fields · synced Jun 10, 2026
- FDA 510(k) K080047 1 fields · synced May 18, 2026