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Ecg247
EUDAMEDClass IIa (EU MDR)
Ref 1Model 353 010Ref 4Ref 2-2Ref 3
by Appsens AS
Identity
- Trade Name
- ECG247 EUDAMED
- Device Name
- ECG247 Sensor EUDAMEDECG247 Software Solution EUDAMEDECG247 Electrode EUDAMEDECG247 APP EUDAMED
- Model / Reference
- 353 010 EUDAMED1 EUDAMED4 EUDAMED2-2 EUDAMED3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07090052220023 EUDAMED07090052220047 EUDAMED07090052220115 EUDAMED07090052220030 EUDAMED
- Basic UDI-DI
- 709005222ECG247SENSORZ2 EUDAMED709005222ECG247SOFTWAREWN EUDAMED709005222ECG247ELECTRODG6 EUDAMED709005222ECG247APP6X EUDAMED
- Direct Marketing DI
- 07090052220023 EUDAMED07090052220047 EUDAMED07090052220115 EUDAMED07090052220030 EUDAMED
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMEDZ12050492 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - MEDICAL DEVICE SOFTWARE EUDAMEDC020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Special Device Type
- Software 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
EUDAMEDEUDAMED
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 (4)
- EUDAMED 1885adcc-0802-404a-a9db-305de9851bef 61 fields · synced Jul 30, 2026
- EUDAMED 6632d430-d716-46df-944a-8927af02b487 61 fields · synced May 17, 2026
- EUDAMED 06b620d7-9f37-4ae2-9fac-658f1d68598c 61 fields · synced May 17, 2026
- EUDAMED 165f97c6-0f61-499f-b930-fb47139920f6 61 fields · synced May 18, 2026