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ECG247 Smart Sensor
EUDAMEDClass IIa (EU MDR)
Ref 4510Model ECG247 model 353 010
by Appsens AS
Identity
- Trade Name
- ECG247 Smart Sensor EUDAMED
- Device Name
- ECG247 Smart Heart Sensor and Electrode Patch EUDAMED
- Model / Reference
- ECG247 model 353 010 EUDAMED4510 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-7090052220061SU EUDAMED
- Basic UDI-DI
- B-7090052220061SU 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-7090052220061SU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Appsens AS
- EUDAMED SRN
- NO-MF-000013438
Sources (1)
- EUDAMED 42655c48-c148-43a8-93c6-e62085916343 61 fields · synced Jun 18, 2026