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Comby EEG cap with 21 Ag/AgCl electrodes
EUDAMEDClass I (EU MDR)
Ref CEC1213742Model COMBY EEG CAP
by Pamel d.o.o.
Identity
- Trade Name
- Comby EEG cap with 21 Ag/AgCl electrodes EUDAMED
- Device Name
- COMBY EEG CAP WITH 5 AG/AGCL EL. EUDAMED
- Model / Reference
- COMBY EEG CAP EUDAMEDCEC1213742 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858894151691 EUDAMED
- Basic UDI-DI
- 385889415COMBYEEGCAPPP EUDAMED
- Direct Marketing DI
- 03858894151691 EUDAMED
- EMDN Code
- N01010203 EEG HEADSETS 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
Comby EEG cap with 21 Ag/AgCl electrodes 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 | 385889415COMBYEEGCAPPP | Class I | Active |
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Manufacturer
- Manufacturer
- Pamel d.o.o.
- EUDAMED SRN
- HR-MF-000028336
Sources (1)
- EUDAMED a7def632-22e7-4c8f-94b2-d2ddfdf2c18f 61 fields · synced Jun 17, 2026