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Disposable Adhesive Surface Electrode
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5797-00-00
Identity
- Trade Name
- Disposable Adhesive Surface Electrode EUDAMEDMagstim FDA UDI
- Generic Name
- Analytical non-scalp cutaneous electrode FDA UDI
- Device Name
- Disposable Adhesive Surface Electrodes EUDAMEDDisposable Adhesive Surface Electrodes, 3-disk, 2.5m twisted + single wire, 10sets FDA UDI
- Model / Reference
- 5797-00-00 EUDAMEDFDA UDI
- Description
- Disposable Adhesive Surface Electrodes, 3-disk, 2.5m twisted + single wire, 10sets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718375868072 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718375868072 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
- Outer Diameter — 20 Millimeter FDA UDILength — 2.5 Meter FDA UDI
Disposable Adhesive Surface Electrode 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-08718375868072 | 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 d3bd7db0-69e8-4e7f-9a87-7f7935d7bca9 61 fields · synced Jul 29, 2026
- FDA UDI fd4d54ad-a9af-4baa-b306-82b3899c1847 35 fields · synced May 30, 2026