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ECG247 Smart Heart Sensor
EUDAMEDClass IIa (EU MDR)
Ref 4000Model ECG247 model 353 010
by Appsens AS
Identity
- Trade Name
- ECG247 Smart Heart Sensor EUDAMED
- Device Name
- ECG247 Smart Heart Sensor System EUDAMED
- Model / Reference
- ECG247 model 353 010 EUDAMED4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-NOMF000013438ECG247P9 EUDAMED
- Basic UDI-DI
- B-NOMF000013438ECG247P9 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 Heart 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-NOMF000013438ECG247P9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Appsens AS
- EUDAMED SRN
- NO-MF-000013438
Sources (1)
- EUDAMED 6ddf0641-f8a9-4af9-ba9f-6205a94117c7 61 fields · synced Jul 27, 2026