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Spare electrode Ag/AgCl / EEG
EUDAMEDClass I (EU MDR)
Ref SPEL10Model ELECUP120
by Pamel d.o.o.
Identity
- Trade Name
- Spare electrode Ag/AgCl / EEG EUDAMED
- Device Name
- electrodes CUP 120cm with sintered Ag/AgCl electrodes EUDAMED
- Model / Reference
- ELECUP120 EUDAMEDSPEL10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858894153794 EUDAMED
- Basic UDI-DI
- 385889415EEGELECTRODESHC EUDAMED
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spare electrode Ag/AgCl / EEG by PAMEL d.o.o. — 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 | 385889415EEGELECTRODESHC | Class I | Active |
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Manufacturer
- Manufacturer
- Pamel d.o.o.
- EUDAMED SRN
- HR-MF-000028336
Sources (1)
- EUDAMED b8e93f7a-92a0-4490-97d9-03c9f3fb0bc5 61 fields · synced Jun 19, 2026