Identity
- Trade Name
- ECG Buddy EUDAMED
- Device Name
- ECG Buddy EUDAMED
- Model / Reference
- ECG Buddy-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809877250035 EUDAMED
- Basic UDI-DI
- 880987725ECGBUDDYFL EUDAMED
- EMDN Code
- Z12050392 ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ECG Buddy by ARPI Inc. — 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 | 880987725ECGBUDDYFL | Class IIa | Active |
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Manufacturer
- Manufacturer
- ARPI Inc.
- EUDAMED SRN
- KR-MF-000044471
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 7fb6ba25-00d9-40a0-86f4-4f012aa6a806 61 fields · synced Jul 23, 2026