← Back to catalogue
Disposable Adhesive Surface Electrode, ground
EUDAMEDFDA UDIClass I (EU MDR)
Ref TE/K50431-003
Identity
- Trade Name
- Disposable Adhesive Surface Electrode, ground EUDAMEDTechnomed Europe FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Disposable Adhesive Surface Electrodes EUDAMEDDisposable Adhesive Surface Electrode, ground 40x50mm 2m wire green 20pcs FDA UDI
- Model / Reference
- TE/K50431-003 EUDAMEDFDA UDI
- Description
- Disposable Adhesive Surface Electrode, ground 40x50mm 2m wire green 20pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720791371562 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
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 2 Meter FDA UDIWidth — 40 Millimeter FDA UDI
Disposable Adhesive Surface Electrode, ground by Technomed Europe — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8718375860002C3 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8718375860002C3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED 8f702a4c-b33e-4e65-bc17-ef986a475a64 61 fields · synced Jul 22, 2026
- FDA UDI 34e304f4-f3de-4b14-be25-8a6492b860cc 35 fields · synced May 30, 2026