Identity
- Trade Name
- Suction chest electrode EUDAMED
- Device Name
- ECG Electrodes EUDAMEDECG Accessories EUDAMED
- Model / Reference
- 60.111.06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033049641066 EUDAMED
- Basic UDI-DI
- 803304054EFELEECGBR EUDAMED803304964EFACCECGG8 EUDAMED
- Unit of Use DI
- 18033049641063 EUDAMED
- EMDN Code
- Z12050380 ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES 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 lead set, reusable
Suction chest electrode by EF Medica Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electrocardiographic lead set, reusable.
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- Unimed — Unimed Medical Supplies, Inc. · Class II
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 (2)
- EUDAMED d987d576-3ff7-4629-9f6f-7818edf706ac 61 fields · synced Jun 19, 2026
- EUDAMED dec99b80-3fbc-4ba5-8912-4a5f5954c116 61 fields · synced Jun 19, 2026