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Standard EEG cap, size 42-47
EUDAMEDClass I (EU MDR)
Ref SEC4247Model SEC3237
by Pamel d.o.o.
Identity
- Trade Name
- Standard EEG cap, size 42-47 EUDAMED
- Device Name
- Standard EEG cap, size 32-37 EUDAMED
- Model / Reference
- SEC3237 EUDAMEDSEC4247 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858894153114 EUDAMED
- Basic UDI-DI
- 385889415STANDARDEEGCAPFM 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Standard EEG cap, size 42-47 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 | 385889415STANDARDEEGCAPFM | Class I | Active |
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Manufacturer
- Manufacturer
- Pamel d.o.o.
- EUDAMED SRN
- HR-MF-000028336
Sources (1)
- EUDAMED 8eb583c3-f435-476b-a324-b9bd1ca44cfe 61 fields · synced Jun 19, 2026