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EEG Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 13-10200-8010Model Precision Gold Disposable EEG ElectrodesRef 13-10100-4010
Identity
- Trade Name
- EEG Electrodes EUDAMEDPrecision Gold FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- Precision Gold EUDAMEDDisposable Gold 9mm Cup EEG Electrode, 40" (1m), 10pack FDA UDIPremium Disposable Gold 9mm Cup EEG Electrode, 80" (2m), 10pack FDA UDI
- Model / Reference
- Precision Gold Disposable EEG Electrodes EUDAMED13-10200-8010 EUDAMEDFDA UDI13-10100-4010 EUDAMEDFDA UDI
- Description
- Disposable Gold 9mm Cup EEG Electrode, 40" (1m), 10pack FDA UDIPremium Disposable Gold 9mm Cup EEG Electrode, 80" (2m), 10pack FDA UDI
Identifiers
- Catalog Number
- SE-250-P FDA UDI
- Primary DI / UDI-DI
- 00817377023071 EUDAMEDFDA UDI00817377022845 EUDAMEDFDA UDI
- Basic UDI-DI
- 08173770213101007G EUDAMED
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES 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
- Portugal 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
EEG Electrodes by Dymedix Diagnostics, Inc. — 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 | 08173770213101007G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dymedix Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000015691
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (4)
- EUDAMED 1b8b88dd-2576-41c9-9a13-ac659dc1069b 61 fields · synced Jul 20, 2026
- FDA UDI fa522a85-d7f4-4ab3-ab74-73bcab330491 34 fields · synced May 29, 2026
- FDA UDI 81b0bdd0-e7fc-492c-8a57-3acbf4300551 33 fields · synced May 30, 2026
- EUDAMED 587b560e-e3c0-4895-9512-a993226c4a75 61 fields · synced Jul 20, 2026