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Comby EEG cap with 21 Ag/AgCl electrodes - MM, size 57-62
EUDAMEDClass I (EU MDR)
Ref CEC1215762MMModel COMBY EEG CAPRef CEC1215257MMRef CEC1213742MMRef CEC1213237MM
by Pamel d.o.o.
Identity
- Trade Name
- Comby EEG cap with 21 Ag/AgCl electrodes - MM, size 57-62 EUDAMEDComby EEG cap with 21 Ag/AgCl electrodes - MM, size 52-57 EUDAMEDComby EEG cap with 21 Ag/AgCl electrodes - MM, size 37-42 EUDAMEDComby EEG cap with 21 Ag/AgCl electrodes - MM, size 32-37 EUDAMED
- Device Name
- COMBY EEG CAP WITH 5 AG/AGCL EL. EUDAMED
- Model / Reference
- COMBY EEG CAP EUDAMEDCEC1215762MM EUDAMEDCEC1215257MM EUDAMEDCEC1213742MM EUDAMEDCEC1213237MM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858894151554 EUDAMED03858894151547 EUDAMED03858894151516 EUDAMED03858894151509 EUDAMED
- Basic UDI-DI
- 385889415COMBYEEGCAPPP EUDAMED
- Direct Marketing DI
- 03858894151554 EUDAMED03858894151547 EUDAMED03858894151516 EUDAMED03858894151509 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 - MM, size 57-62 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 (4)
- EUDAMED 853f63be-65ac-4a92-8388-8e11a84daf67 61 fields · synced Jul 15, 2026
- EUDAMED f73528cb-76fc-409c-810c-4e6255ba1736 61 fields · synced May 17, 2026
- EUDAMED 02a45cd3-f200-4921-803f-34b187906b4d 61 fields · synced May 18, 2026
- EUDAMED f3cfa728-724e-444a-8d82-bcb16d249bdb 61 fields · synced May 19, 2026