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EEG Electrodes
EUDAMEDFDA UDIClass I (EU MDR)
Ref 13-10200-1010Model Precision Gold Disposable EEG Electrodes
Identity
- Trade Name
- EEG Electrodes EUDAMEDPrecision Gold FDA UDI
- Generic Name
- Analytical scalp electrode, single-use FDA UDI
- Device Name
- Precision Gold EUDAMEDPremium Disposable Adult EEG 9mm Cup Electrodes 2.5m (10 colored wires) FDA UDI
- Model / Reference
- Precision Gold Disposable EEG Electrodes EUDAMED13-10200-1010 EUDAMEDFDA UDI
- Description
- Premium Disposable Adult EEG 9mm Cup Electrodes 2.5m (10 colored wires) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817377023064 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
- Spain 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 (2)
- EUDAMED 117745d3-5793-4c87-9c6c-27b030d2aef3 61 fields · synced Jun 20, 2026
- FDA UDI 5078d932-c0e1-4e1f-b0e3-55478de7111f 33 fields · synced May 30, 2026