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ECG247 Smart Sensor
EUDAMEDClass IIa (EU MDR)
Ref 4504Model ECG247 model 353 010Ref 002Model ECG247 Smart Sensor, model 353 010Ref 001Model ECG247 Smart Sensor model 353 010
by Appsens AS
Identity
- Trade Name
- ECG247 Smart Sensor EUDAMEDECG247 Smart Sensor and Electrode EUDAMED
- Device Name
- ECG247 Smart Heart Sensor EUDAMEDECG247 Smart Sensor EUDAMEDECG247 Smart Sensor and Electrode EUDAMED
- Model / Reference
- ECG247 model 353 010 EUDAMED4504 EUDAMEDECG247 Smart Sensor, model 353 010 EUDAMED002 EUDAMEDECG247 Smart Sensor model 353 010 EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-7090052220054SX EUDAMEDD-7022750045004SF EUDAMEDD-7090052220009SS EUDAMED
- Basic UDI-DI
- B-7090052220054SX EUDAMEDB-7022750045004SF EUDAMEDB-7090052220009SS EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ECG247 Smart Sensor by Appsens AS — 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-7090052220054SX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Appsens AS
- EUDAMED SRN
- NO-MF-000013438
Sources (3)
- EUDAMED de1cfc7e-4445-4cb2-95ed-c00bab86f1cf 61 fields · synced Jul 25, 2026
- EUDAMED f48f24b2-ebfc-45b9-9680-84945913e9f7 61 fields · synced May 17, 2026
- EUDAMED 73dc3120-b801-4908-9d2c-ff7581fc2772 61 fields · synced May 18, 2026