Identity
- Trade Name
- DuraPad EUDAMED
- Device Name
- Self-Adhesive Electrode EUDAMED
- Model / Reference
- SAE-SC040000WP-VT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872332183 EUDAMED
- Basic UDI-DI
- 471987233SAEQ6 EUDAMED
- Direct Marketing DI
- 04719872332183 EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
DuraPad by ZMI Electronics Ltd. — 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 | 471987233SAEQ6 | Class I | Active |
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Manufacturer
- Manufacturer
- ZMI Electronics Ltd.
- EUDAMED SRN
- TW-MF-000003571
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED ccd0757c-a6a9-4c10-a726-0fd3e97ca649 61 fields · synced Jul 30, 2026