Identity
- Trade Name
- Rubber foam profile fi 5mm EUDAMED
- Device Name
- Rubber foam profile fi 5mm EUDAMED
- Model / Reference
- SR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03858894154357 EUDAMED
- Basic UDI-DI
- 385889415EEGACCESSORIESHN 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
No
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
Rubber foam profile fi 5mm 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 | 385889415EEGACCESSORIESHN | Class I | Active |
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Manufacturer
- Manufacturer
- Pamel d.o.o.
- EUDAMED SRN
- HR-MF-000028336
Sources (1)
- EUDAMED 0dcaa230-4224-4923-aa4f-47ac6e5575c2 61 fields · synced Jun 19, 2026