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Comby EEG cap with 22 Ag/AgCl electrodes, size 52-57, red
EUDAMEDFDA UDIClass I (EU MDR)
Ref CEC1225257Model COMBY EEG CAP
by Pamel d.o.o.
Identity
- Trade Name
- Comby EEG cap with 22 Ag/AgCl electrodes, size 52-57, red EUDAMEDCOMBY EEG CAP FDA UDI
- Generic Name
- Electroencephalographic electrode cap, reusable FDA UDI
- Device Name
- COMBY EEG CAP WITH 5 AG/AGCL EL. EUDAMEDComby EEG cap with 22 Ag/AgCl sintered electrodes, size 52-57 FDA UDI
- Model / Reference
- COMBY EEG CAP EUDAMEDCEC1225257 EUDAMEDComby EEG Cap/ 22 Ag/AgCl EL. FDA UDI
- Description
- Comby EEG cap with 22 Ag/AgCl sintered electrodes, size 52-57 FDA UDI
Identifiers
- Catalog Number
- CEC1225257 FDA UDI
- Primary DI / UDI-DI
- 03858894151967 EUDAMEDFDA UDI
- Basic UDI-DI
- 385889415COMBYEEGCAPPP EUDAMED
- Direct Marketing DI
- 03858894151967 EUDAMED
- 510(k) Number
- K211315 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
- GMDN Term
- Electroencephalographic electrode cap, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Croatia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Comby EEG cap with 22 Ag/AgCl electrodes, size 52-57, red by PAMEL d.o.o. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 385889415COMBYEEGCAPPP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pamel d.o.o.
- EUDAMED SRN
- HR-MF-000028336
Sources (2)
- EUDAMED 461e751d-ab53-494d-bc65-792d510b734c 61 fields · synced Jun 18, 2026
- FDA UDI 202bc71e-d9c6-44f5-b9cc-32cbb1ce2425 36 fields · synced May 29, 2026