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Disposable EEG Cup+ Electrode Ag/AgCl coated
EUDAMEDFDA UDIClass I (EU MDR)
Ref C53-638
Identity
- Trade Name
- Disposable EEG Cup+ Electrode Ag/AgCl coated EUDAMEDCNS - Neuroguard FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- EEG cup electrodes EUDAMEDDisposable EEG Cup+ Electrode Ag/AgCl coated 10mm cup 1.5m wire 25pc FDA UDI
- Model / Reference
- C53-638 EUDAMEDFDA UDI
- Description
- Disposable EEG Cup+ Electrode Ag/AgCl coated 10mm cup 1.5m wire 25pc FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791375126 EUDAMEDFDA UDI
- Basic UDI-DI
- 8718375860003C5 EUDAMED
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N01010299 EEG ELECTRODES - OTHER EUDAMED
- GMDN Term
- Analytical scalp electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 1.5 Meter FDA UDIOuter Diameter — 10 Millimeter FDA UDI
Disposable EEG Cup+ Electrode Ag/AgCl coated by Technomed Europe — 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 | 8718375860003C5 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED 959077f7-9378-4c1f-bfad-6682d8a16d6d 61 fields · synced Jun 18, 2026
- FDA UDI abc9ba66-9c45-4f40-adc2-0191e5149e23 35 fields · synced May 29, 2026