Identity
- Trade Name
- Rolls for Cardioswift/Contec/Somo EUDAMED
- Device Name
- ECG Electrodes EUDAMED
- Model / Reference
- 10.110.23 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033040543888 EUDAMED
- Basic UDI-DI
- 803304054EFELEECGBR EUDAMED
- Unit of Use DI
- 18033040543885 EUDAMED
- EMDN Code
- Z1302 DIAGNOSTIC REGISTRATION PAPERS 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
Rolls for Cardioswift/Contec/Somo by EF Medica Srl — Class I — 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 | 803304054EFELEECGBR | Class I | Active |
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Manufacturer
- Manufacturer
- EF Medica Srl
- EUDAMED SRN
- IT-MF-000009938
Sources (1)
- EUDAMED 8734d454-8637-43e0-94ee-58be1451c2ae 61 fields · synced Jun 18, 2026