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Electrode CUP 5 SET 120 mm with sintered Ag/AgCl electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref ELECUP5SET120Model ELECUP120
by Pamel d.o.o.
Identity
- Trade Name
- Electrode CUP 5 SET 120 mm with sintered Ag/AgCl electrodes EUDAMEDCOMBY EEG CAP FDA UDI
- Generic Name
- Analytical scalp electrode, reusable FDA UDI
- Device Name
- electrodes CUP 120cm with sintered Ag/AgCl electrodes EUDAMEDElectrode CUP 5 SET 120 mm with sintered Ag/AgCl electrodes FDA UDI
- Model / Reference
- ELECUP120 EUDAMEDELECUP5SET120 EUDAMEDELECUP120 - CUP Ag/AgCl electrode FDA UDI
- Description
- Electrode CUP 5 SET 120 mm with sintered Ag/AgCl electrodes FDA UDI
Identifiers
- Catalog Number
- ELECUP5SET120 FDA UDI
- Primary DI / UDI-DI
- 03858894153183 EUDAMEDFDA UDI
- Basic UDI-DI
- 385889415EEGELECTRODESHC EUDAMED
- 510(k) Number
- K211315 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N01010203 EEG HEADSETS EUDAMED
- GMDN Term
- Analytical scalp electrode, 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
Electrode CUP 5 SET 120 mm with sintered Ag/AgCl electrodes by PAMEL d.o.o. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 385889415EEGELECTRODESHC | 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 eb2c0855-c39c-41c8-93e8-e1f62d77185b 61 fields · synced Jul 14, 2026
- FDA UDI be535f16-20b6-4d7d-b414-7c0c912daede 36 fields · synced May 30, 2026