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ECG247 Smart Sensor APP
EUDAMEDClass IIa (EU MDR)
Ref 003Model ECG247APP
by Appsens AS
Identity
- Trade Name
- ECG247 Smart Sensor APP EUDAMED
- Device Name
- ECG247 APP to be used with ECG247 Smart Sensor EUDAMED
- Model / Reference
- ECG247APP EUDAMED003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-7090052220030SH EUDAMED
- Basic UDI-DI
- B-7090052220030SH EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 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 APP 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-7090052220030SH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Appsens AS
- EUDAMED SRN
- NO-MF-000013438
Sources (1)
- EUDAMED 7300a5e9-4e9d-45f2-8a67-45008491a104 61 fields · synced Jun 19, 2026