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Silver Conductive Electrode
EUDAMEDFDA UDIClass I (EU MDR)
Ref 09Model KM-406/KM-407/KM-408/KM-409/KM-410
Identity
- Trade Name
- Konmed FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Silver Conductive Electrode EUDAMEDElectrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve, elbow Sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution. FDA UDI
- Model / Reference
- KM-406/KM-407/KM-408/KM-409/KM-410 EUDAMED09 EUDAMEDKM-406 FDA UDI
- Description
- Electrodes with silver conductive are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, wrist sleeve, elbow Sleeve and knee sleeve. The conductivity is derived from the silver content of the Nylon yarn. The electrodes are available in free size. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The electrodes can be used dry or wet when in contact with the skin. The entire surface of each electrode is very conductive having a resistance of less than 2ohms per inch. This low resistance provides low current density with uniform current distribution. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970935830024 EUDAMEDFDA UDI
- Basic UDI-DI
- 697093583KM400JS EUDAMED
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation 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
No
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
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silver Conductive Electrode by Shenzhen Konmed Technology Co., Ltd. — 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 | 697093583KM400JS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Konmed Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018375
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 65ff2d6e-b152-45ac-80d3-4aed3ec63bb4 61 fields · synced Jul 17, 2026
- FDA UDI 7f3b4e21-2b5f-45e7-9de3-2721eb2e1a75 33 fields · synced May 30, 2026