Identity
- Trade Name
- Elettrodo per ECG EUDAMED
- Device Name
- Elettrodo per ECG 105162 EUDAMED
- Model / Reference
- Elettrodo per ECG EUDAMED105162 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053470800597 EUDAMED
- Basic UDI-DI
- 805347080059C6 EUDAMED
- EMDN Code
- C020501 ECG ELECTRODES EUDAMED
Classification
- Device Class
- Class I 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
Category: Electrocardiographic electrode, single-use
Elettrodo per ECG by Gammadis Farmaceutici Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic electrode, single-use.
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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 | 805347080059C6 | Class I | Active |
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Manufacturer
- Manufacturer
- Gammadis Farmaceutici Srl
- EUDAMED SRN
- IT-MF-000032982
Sources (1)
- EUDAMED bcf09426-0be1-4eaf-8a41-e5bcc9cdd783 61 fields · synced Jul 11, 2026