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Disposable Adhesive Surface Electrode, ground
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref TE/K50431-002
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 1m wire green 20pcs FDA UDI
- Model / Reference
- TE/K50431-002 EUDAMEDFDA UDI
- Description
- Disposable Adhesive Surface Electrode, ground 40x50mm 1m wire green 20pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375862964 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375862964 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 IIa 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
Dimensions & Sizes
- Size
- Width — 40 Millimeter FDA UDILength — 1.0 Meter FDA UDI
Disposable Adhesive Surface Electrode, ground by Technomed Europe — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08718375862964 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Technomed Europe
- EUDAMED SRN
- NL-MF-000000064
Sources (2)
- EUDAMED 367de1cb-a3dc-4abf-bf4b-cad4b1e0023a 61 fields · synced Jul 11, 2026
- FDA UDI 558c6a2f-2554-41dd-98a2-501e2563fc24 35 fields · synced May 30, 2026