Identity
- Trade Name
- smartheart EUDAMED
- Device Name
- smartheart EUDAMED
- Model / Reference
- E-XXX-X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290008960380 EUDAMED
- Basic UDI-DI
- B-07290008960380 EUDAMED
- EMDN Code
- Z12050803 ELECTROCARDIOGRAPH TELEMETRY SYSTEM TRANSMITTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
smartheart by Shl Telemedicine International Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290008960380 | 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 (1)
- EUDAMED 05aa739c-6e7b-4e0a-b823-f3be6f716421 61 fields · synced Jul 16, 2026