Identity
- Device Name
- ECGWebApp EUDAMEDECGWebApp Holter EUDAMED
- Model / Reference
- 81019560 EUDAMED81019595 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056732652514 EUDAMED08056732652927 EUDAMED
- Basic UDI-DI
- B-08056732652514 EUDAMED0805673265012000015A EUDAMED
- Direct Marketing DI
- 08056732652927 EUDAMED
- EMDN Code
- Z12059009 ECG DATA MANAGEMENT SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Special Device Type
- -1192 EUDAMEDSoftware EUDAMED
- Market of Registration
- Italy 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
ECGWebApp by Cardioline Spa — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08056732652514 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08056732652514 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CARDIOLINE SpA
- EUDAMED SRN
- IT-MF-000029682
Sources (2)
- EUDAMED 5bdf7d9f-52a3-425a-9dfa-d6214a3a479f 61 fields · synced Jul 18, 2026
- EUDAMED 09d162c2-6895-4a32-9314-d4d5078d9122 61 fields · synced May 18, 2026