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Disposable EEG Cup Electrode Ag/AgCl coated
EUDAMEDFDA UDIClass I (EU MDR)
Ref TE/C53-438Ref C53-632Ref TE/C52-838Ref TE/C53-938Ref TE/C53-638
Identity
- Trade Name
- Disposable EEG Cup Electrode Ag/AgCl coated EUDAMEDDisposable EEG Cup+ Electrode Ag/AgCl coated EUDAMEDNeuroguard 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, 10pcs FDA UDI
- Model / Reference
- TE/C53-438 EUDAMEDC53-632 EUDAMEDFDA UDITE/C52-838 EUDAMEDTE/C53-938 EUDAMEDTE/C53-638 EUDAMED
- Description
- Disposable EEG Cup+ Electrode Ag/AgCl coated, 10mm cup, 1.5m wire, 10pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791378592 EUDAMED08720791370619 EUDAMEDFDA UDI08720791378578 EUDAMED08720791378622 EUDAMED08720791378608 EUDAMED
- 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
- Outer Diameter — 10 Millimeter FDA UDILength — 1.5 Meter 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 (6)
- EUDAMED 949d4ec6-0b7a-4ee5-8c8d-51383ff93b28 61 fields · synced Jul 25, 2026
- EUDAMED 6ce2b15c-4360-401c-8f49-83ae8ecbc963 61 fields · synced May 18, 2026
- EUDAMED 97d20be0-d026-4769-9fc7-4392a80d5fec 61 fields · synced May 18, 2026
- EUDAMED c69763e8-adc5-45ca-abc1-e10bb2c6f5fa 61 fields · synced May 19, 2026
- EUDAMED 0585b006-9f77-4ec1-b262-ad7f2c398cda 61 fields · synced May 19, 2026
- FDA UDI 887de6fc-31df-4d05-bd3f-cfc7b58ee8fe 35 fields · synced May 30, 2026