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Comby EEG cap with 20 Ag/AgCl electrodes - SIGMA, size 57-62, green
EUDAMEDClass I (EU MDR)
Ref CEC1205762SModel COMBY EEG CAPRef CEC1203742SRef CEC1202327SRef CEC1204752SRef CEC1205257S
by Pamel d.o.o.
Identity
- Trade Name
- Comby EEG cap with 20 Ag/AgCl electrodes - SIGMA, size 57-62, green EUDAMEDComby EEG cap with 20 Ag/AgCl electrodes - SIGMA, size 37-42, red EUDAMEDComby EEG cap with 20 Ag/AgCl electrodes - SIGMA, size 23-27, yellow EUDAMEDComby EEG cap with 20 Ag/AgCl electrodes - SIGMA, size 47-52, yellow EUDAMEDComby EEG cap with 20 Ag/AgCl electrodes - SIGMA, size 52-57, red EUDAMED
- Device Name
- COMBY EEG CAP WITH 5 AG/AGCL EL. EUDAMED
- Model / Reference
- COMBY EEG CAP EUDAMEDCEC1205762S EUDAMEDCEC1203742S EUDAMEDCEC1202327S EUDAMEDCEC1204752S EUDAMEDCEC1205257S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858894150885 EUDAMED03858894150847 EUDAMED03858894150823 EUDAMED03858894150861 EUDAMED03858894150878 EUDAMED
- Basic UDI-DI
- 385889415COMBYEEGCAPPP EUDAMED
- Direct Marketing DI
- 03858894150885 EUDAMED03858894150847 EUDAMED03858894150823 EUDAMED03858894150861 EUDAMED03858894150878 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 20 Ag/AgCl electrodes - SIGMA, size 57-62, green 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 (5)
- EUDAMED 231699a5-f1f1-44ef-8bb7-d06a5397df88 61 fields · synced Jul 28, 2026
- EUDAMED db0cd4ab-651b-474d-a8d5-75e56c9c9782 61 fields · synced May 17, 2026
- EUDAMED f97357c3-7c38-48d9-b039-2a1ade5d860e 61 fields · synced May 18, 2026
- EUDAMED 7e6e8877-7dc6-4841-87c9-93c78ec0bca1 61 fields · synced May 18, 2026
- EUDAMED d168502b-1994-4b28-b5ea-280b86990220 61 fields · synced May 18, 2026