Identity
- Trade Name
- Rubber belt EUDAMED
- Device Name
- ECG Accessories EUDAMED
- Model / Reference
- 60.115.03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18033049641247 EUDAMED
- Basic UDI-DI
- 803304964EFACCECGG8 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
Yes
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
Rubber belt by EF Medica Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 803304964EFACCECGG8 | Class I | Active |
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Manufacturer
- Manufacturer
- EF Medica Srl
- EUDAMED SRN
- IT-MF-000009938
Sources (1)
- EUDAMED 3ca9bf7b-e028-4517-9965-c4f98f23dfbf 61 fields · synced Jul 28, 2026