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Disposable Adhesive Surface Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref K50430-001
Identity
- Trade Name
- Disposable Adhesive Surface Electrode EUDAMEDNeuroguard FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Disposable Adhesive Surface Electrodes EUDAMEDDisposable Adhesive Surface Electrode, 4-Disk 20mm 1m wire 4 colors 10sets FDA UDI
- Model / Reference
- K50430-001 EUDAMEDFDA UDI
- Description
- Disposable Adhesive Surface Electrode, 4-Disk 20mm 1m wire 4 colors 10sets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791374532 EUDAMEDFDA UDI
- Basic UDI-DI
- 8718375860002C3 EUDAMED
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous electrode 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 20 Millimeter FDA UDILength — 1.0 Meter FDA UDI
Disposable Adhesive Surface Electrode 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 | 8718375860002C3 | 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 9ff7b7ec-8e21-46fa-9e11-635b2a2dda8f 61 fields · synced Jul 12, 2026
- FDA UDI f566af88-6297-4bb4-949e-3a033a47f589 35 fields · synced May 30, 2026