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electrode pad
EUDAMEDFDA UDIClass I (EU MDR)
Ref CWN2505Model CWNXXXX(OCWNXXXX) series, CWTXXXX series,CWFXXXX series, DWNXXXX series, DWTXXXX series,DWFXXXX series,QWNXXXX series,QWTXXXX series,QWFXXXX series, ACWNXXXX(AWNXXXX, OACWNXXXX) series, ACWTXXXX series，ACWFXXXX(AWFXXXX) series, ACWWXXXX(ACGWXXXX)series
Identity
- Trade Name
- electrode pad EUDAMEDNA FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- Electrode pad EUDAMEDElectrode pad, prewired, 1 pack of 4pcs, white cloth backing FDA UDI
- Model / Reference
- CWNXXXX(OCWNXXXX) series, CWTXXXX series,CWFXXXX series, DWNXXXX series, DWTXXXX series,DWFXXXX series,QWNXXXX series,QWTXXXX series,QWFXXXX series, ACWNXXXX(AWNXXXX, OACWNXXXX) series, ACWTXXXX series，ACWFXXXX(AWFXXXX) series, ACWWXXXX(ACGWXXXX)series EUDAMEDCWN2505 EUDAMEDFDA UDI
- Description
- Electrode pad, prewired, 1 pack of 4pcs, white cloth backing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970341670016 EUDAMEDFDA UDI
- Basic UDI-DI
- 697034167099HN EUDAMED
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, reusable 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
electrode pad by Gmdasz Manufacturing 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 | 697034167099HN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GMDASZ Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000011760
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED dd5ecb10-0604-40df-8c90-e94feb7670d0 61 fields · synced Jul 14, 2026
- FDA UDI 5c13f16e-11e3-4211-8f19-420a5855dd6a 34 fields · synced May 24, 2026