Identity
- Trade Name
- ECG247 EUDAMED
- Device Name
- ECG247 Sensor EUDAMED
- Model / Reference
- 353 010 EUDAMED1-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07090052220054 EUDAMED
- Basic UDI-DI
- 709005222ECG247SENSORZ2 EUDAMED
- Direct Marketing DI
- 07090052220054 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ecg247 by Appsens AS — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 709005222ECG247SENSORZ2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Appsens AS
- EUDAMED SRN
- NO-MF-000013438
Sources (1)
- EUDAMED 4ef5e669-c6dc-4add-8bc2-b91194024cd7 61 fields · synced Jun 19, 2026