Identity
- Trade Name
- Clamp electrode EUDAMED
- Device Name
- ECG Electrodes EUDAMEDECG Accessories EUDAMED
- Model / Reference
- 60.100.04 EUDAMED60.100.02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033049640977 EUDAMED08033049640953 EUDAMED
- Basic UDI-DI
- 803304054EFELEECGBR EUDAMED803304964EFACCECGG8 EUDAMED
- Unit of Use DI
- 18033049640974 EUDAMED18033049640950 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
Clamp 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
- Unimed — Unimed Medical Supplies, Inc. · Class II
- ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
- Unimed — Unimed Medical Supplies, Inc. · Class II
- 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 (4)
- EUDAMED 97b7fd9a-1aec-47c6-bd6d-a52d6b7a53a3 61 fields · synced Sep 18, 2026
- EUDAMED 48718202-7c84-4e5b-8667-ac8d76ee4f1a 61 fields · synced May 18, 2026
- EUDAMED eeeeb27c-7ffe-4a0a-a3e7-ec547ec5a10f 61 fields · synced Jul 15, 2026
- EUDAMED 90d25342-f831-424c-bfa8-bf08ecc26fa4 61 fields · synced Sep 18, 2026