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smartheart
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref E-467-XModel smartheart
Identity
- Trade Name
- smartheart EUDAMEDFDA UDI
- Generic Name
- Electrocardiograph, home-use FDA UDI
- Device Name
- smartheart EUDAMEDThe smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with Bluetooth connection. The smartheart acquires EGG data via attached electrodes. The smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results. FDA UDI
- Model / Reference
- smartheart EUDAMEDE-467-X EUDAMED3.3 FDA UDI
- Description
- The smartheart is a personal, hand-held battery powered, 12 lead EG and rhythm strip device with Bluetooth connection. The smartheart acquires EGG data via attached electrodes. The smartheart transmits the data in real-time to a suitable Bluetooth communication device for forwarding it to a remote location and a certified medical professional capable of interpreting the results. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290008960359 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290008960359 EUDAMED
- 510(k) Number
- K113514 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
- Height — 1.5 Centimeter FDA UDIWidth — 8.5 Centimeter FDA UDILength — 11 Centimeter FDA UDIWeight — 110 Gram FDA UDI
smartheart 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 | K113514 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-07290008960359 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SHL Telemedicine International Ltd.
- EUDAMED SRN
- IL-MF-000021473
- Authorised Representative
- SHL Telemedizin GmbH DE-AR-000016273
Sources (3)
- EUDAMED ab933c47-fd03-4321-bf00-3806be850504 61 fields · synced Jun 19, 2026
- FDA UDI 7599ae3c-ef76-47af-bde9-12a7e0e5b8c2 37 fields · synced May 30, 2026
- FDA 510(k) K113514 1 fields · synced May 18, 2026