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Electrode Sponge
EUDAMEDClass I (EU MDR)
Ref SPS-P-100137-DJRef SPS-P-100137Ref SPS-R-05031Ref SPS-P-070080Ref SPS-P-100137-DJ2Ref SPS-P-070080-DJ
Identity
- Device Name
- Electrode Sponge EUDAMED
- Model / Reference
- SPS-P-100137-DJ EUDAMEDSPS-P-100137 EUDAMEDSPS-R-05031 EUDAMEDSPS-P-070080 EUDAMEDSPS-P-100137-DJ2 EUDAMEDSPS-P-070080-DJ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872333197 EUDAMED04719872330974 EUDAMED04719872330981 EUDAMED04719872330950 EUDAMED04719872333203 EUDAMED04719872333173 EUDAMED
- Basic UDI-DI
- 471987233SPSSF EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDGermany 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
Electrode Sponge 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 | 471987233SPSSF | 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 (6)
- EUDAMED 226a59de-8731-409c-ada2-9b1dec4d0289 61 fields · synced Jul 27, 2026
- EUDAMED ddb2ab32-60a0-483c-ae9f-1a0e9dd52241 61 fields · synced May 17, 2026
- EUDAMED d0533029-a5eb-4af8-9adf-5e10d7a10882 61 fields · synced May 18, 2026
- EUDAMED ca4f5959-4cbb-4c48-8628-5a4ea8f71c3b 61 fields · synced May 18, 2026
- EUDAMED 5767a6d0-d414-4f3f-9c90-e3ad98e12205 61 fields · synced May 18, 2026
- EUDAMED 386a6d20-6350-40cd-90ae-6d7004ba2d4a 61 fields · synced May 19, 2026