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electrode pad
EUDAMEDClass I (EU MDR)
Ref CWN2509Model 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 EUDAMED
- Device Name
- Electrode pad EUDAMED
- 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 EUDAMEDCWN2509 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970341670795 EUDAMED
- Basic UDI-DI
- 697034167099HN EUDAMED
- EMDN Code
- N010201 TENS SYSTEM ELECTRODES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovenia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
electrode pad by Gmdasz Manufacturing Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697034167099HN | Class I | Active |
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Manufacturer
- Manufacturer
- GMDASZ Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000011760
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED f8dd8c10-554e-4b3c-8273-543718a3fc62 61 fields · synced Jun 18, 2026